Katherine Zhou
@katherinezhoumd.bsky.social
Duke Hematology-Oncology Fellow. Interested in RNA, GI oncology, and predictive biomarkers. Alum of Duke IM Residency, UChicago Pritzker School of Medicine, Yale College.
Not sure about ampullary, but this ASCO 2024 poster found CLDN18.2 IHC 2+/3+ in 35% of small bowel adenocarcinomas (including 49% duodenal)
doi.org/10.1200/JCO.2024.42.16_suppl.4176
doi.org/10.1200/JCO.2024.42.16_suppl.4176
February 5, 2025 at 2:46 AM
Not sure about ampullary, but this ASCO 2024 poster found CLDN18.2 IHC 2+/3+ in 35% of small bowel adenocarcinomas (including 49% duodenal)
doi.org/10.1200/JCO.2024.42.16_suppl.4176
doi.org/10.1200/JCO.2024.42.16_suppl.4176
#PostTest Q2️⃣ #TumorBoardTuesday
👉🏽 Free CME 🔗 integrityce.com/TBT2024
🧐 Which of the following would you select for a 78-year-old man w/ mPDAC (CLDN18.2, 45%; MSS; gBRCA WT) and disease progression after gemcitabine/abraxane❓
1) FOLFIRINOX
2) Regorafenib trial
3) CLDN18.2 BiTe trial
4) Pembrolizumab
👉🏽 Free CME 🔗 integrityce.com/TBT2024
🧐 Which of the following would you select for a 78-year-old man w/ mPDAC (CLDN18.2, 45%; MSS; gBRCA WT) and disease progression after gemcitabine/abraxane❓
1) FOLFIRINOX
2) Regorafenib trial
3) CLDN18.2 BiTe trial
4) Pembrolizumab
February 5, 2025 at 2:06 AM
#PostTest Q2️⃣ #TumorBoardTuesday
👉🏽 Free CME 🔗 integrityce.com/TBT2024
🧐 Which of the following would you select for a 78-year-old man w/ mPDAC (CLDN18.2, 45%; MSS; gBRCA WT) and disease progression after gemcitabine/abraxane❓
1) FOLFIRINOX
2) Regorafenib trial
3) CLDN18.2 BiTe trial
4) Pembrolizumab
👉🏽 Free CME 🔗 integrityce.com/TBT2024
🧐 Which of the following would you select for a 78-year-old man w/ mPDAC (CLDN18.2, 45%; MSS; gBRCA WT) and disease progression after gemcitabine/abraxane❓
1) FOLFIRINOX
2) Regorafenib trial
3) CLDN18.2 BiTe trial
4) Pembrolizumab
#PostTest Q1️⃣ #TumorBoardTuesday
👉🏽#CME Eval 🔗 integrityce.com/TBTeval24
👉🏽ALL CME🔗 integrityce.com/TBT2024
🤔What percentage of pancreatic adenocarcinoma cases typically express Claudin 18.2?
1) 30%
2) 50%
3) 70%
4) 90%
👉🏽#CME Eval 🔗 integrityce.com/TBTeval24
👉🏽ALL CME🔗 integrityce.com/TBT2024
🤔What percentage of pancreatic adenocarcinoma cases typically express Claudin 18.2?
1) 30%
2) 50%
3) 70%
4) 90%
February 5, 2025 at 2:03 AM
#PostTest Q1️⃣ #TumorBoardTuesday
👉🏽#CME Eval 🔗 integrityce.com/TBTeval24
👉🏽ALL CME🔗 integrityce.com/TBT2024
🤔What percentage of pancreatic adenocarcinoma cases typically express Claudin 18.2?
1) 30%
2) 50%
3) 70%
4) 90%
👉🏽#CME Eval 🔗 integrityce.com/TBTeval24
👉🏽ALL CME🔗 integrityce.com/TBT2024
🤔What percentage of pancreatic adenocarcinoma cases typically express Claudin 18.2?
1) 30%
2) 50%
3) 70%
4) 90%
31/31 #TumorBoardTuesday
🏫Mini Tutorial 27🏫
Choice of CLDN18.2 BiTE vs CAR-T?
BiTE: off the shelf, continuous therapy
CAR-T: autologous (takes time), one infusion
doi.org/10.1186/s13045-021-01067-5
🏫Mini Tutorial 27🏫
Choice of CLDN18.2 BiTE vs CAR-T?
BiTE: off the shelf, continuous therapy
CAR-T: autologous (takes time), one infusion
doi.org/10.1186/s13045-021-01067-5
February 5, 2025 at 2:00 AM
31/31 #TumorBoardTuesday
🏫Mini Tutorial 27🏫
Choice of CLDN18.2 BiTE vs CAR-T?
BiTE: off the shelf, continuous therapy
CAR-T: autologous (takes time), one infusion
doi.org/10.1186/s13045-021-01067-5
🏫Mini Tutorial 27🏫
Choice of CLDN18.2 BiTE vs CAR-T?
BiTE: off the shelf, continuous therapy
CAR-T: autologous (takes time), one infusion
doi.org/10.1186/s13045-021-01067-5
30/31 #TumorBoardTuesday
🏫Mini Tutorial 26🏫
3) BiTE+OV
Oncolytic virus -> tumor lysis -> T cell response
SQ model of KPC w/ human CLDN18.2 in CD3ε humanized mice:
OV-BiTE improved tumor control and survival compared to OV-GFP or PBS ctrl
doi.org/10.1016/j.omto.2023.08.011
🏫Mini Tutorial 26🏫
3) BiTE+OV
Oncolytic virus -> tumor lysis -> T cell response
SQ model of KPC w/ human CLDN18.2 in CD3ε humanized mice:
OV-BiTE improved tumor control and survival compared to OV-GFP or PBS ctrl
doi.org/10.1016/j.omto.2023.08.011
February 5, 2025 at 1:58 AM
30/31 #TumorBoardTuesday
🏫Mini Tutorial 26🏫
3) BiTE+OV
Oncolytic virus -> tumor lysis -> T cell response
SQ model of KPC w/ human CLDN18.2 in CD3ε humanized mice:
OV-BiTE improved tumor control and survival compared to OV-GFP or PBS ctrl
doi.org/10.1016/j.omto.2023.08.011
🏫Mini Tutorial 26🏫
3) BiTE+OV
Oncolytic virus -> tumor lysis -> T cell response
SQ model of KPC w/ human CLDN18.2 in CD3ε humanized mice:
OV-BiTE improved tumor control and survival compared to OV-GFP or PBS ctrl
doi.org/10.1016/j.omto.2023.08.011
29/31 #TumorBoardTuesday
🏫Mini Tutorial 25🏫
2) BiTE+ICI
BiTEs -> inhibitory checkpoints upregulated
KPC orthotopic model:
CLDN18.2 x CD3 BiTE + αPD1 -> decreased tumor growth compared to BiTE or αPD1 alone
doi.org/10.1053/j.gastro.2023.06.037
🏫Mini Tutorial 25🏫
2) BiTE+ICI
BiTEs -> inhibitory checkpoints upregulated
KPC orthotopic model:
CLDN18.2 x CD3 BiTE + αPD1 -> decreased tumor growth compared to BiTE or αPD1 alone
doi.org/10.1053/j.gastro.2023.06.037
February 5, 2025 at 1:57 AM
29/31 #TumorBoardTuesday
🏫Mini Tutorial 25🏫
2) BiTE+ICI
BiTEs -> inhibitory checkpoints upregulated
KPC orthotopic model:
CLDN18.2 x CD3 BiTE + αPD1 -> decreased tumor growth compared to BiTE or αPD1 alone
doi.org/10.1053/j.gastro.2023.06.037
🏫Mini Tutorial 25🏫
2) BiTE+ICI
BiTEs -> inhibitory checkpoints upregulated
KPC orthotopic model:
CLDN18.2 x CD3 BiTE + αPD1 -> decreased tumor growth compared to BiTE or αPD1 alone
doi.org/10.1053/j.gastro.2023.06.037
28/31 #TumorBoardTuesday
🏫Mini Tutorial 24🏫
How about CLDN18.2 BiTE+X combos?
1) BiTE+chemo
Chemo increases immunogenicity, depletes immunosuppressive Tregs (CD3-targeting BiTEs recruit polyclonal T cells, including Tregs)
NCT05365581: ASP2138 (CD3 x CLDN18.2) ± chemo
🏫Mini Tutorial 24🏫
How about CLDN18.2 BiTE+X combos?
1) BiTE+chemo
Chemo increases immunogenicity, depletes immunosuppressive Tregs (CD3-targeting BiTEs recruit polyclonal T cells, including Tregs)
NCT05365581: ASP2138 (CD3 x CLDN18.2) ± chemo
February 5, 2025 at 1:55 AM
28/31 #TumorBoardTuesday
🏫Mini Tutorial 24🏫
How about CLDN18.2 BiTE+X combos?
1) BiTE+chemo
Chemo increases immunogenicity, depletes immunosuppressive Tregs (CD3-targeting BiTEs recruit polyclonal T cells, including Tregs)
NCT05365581: ASP2138 (CD3 x CLDN18.2) ± chemo
🏫Mini Tutorial 24🏫
How about CLDN18.2 BiTE+X combos?
1) BiTE+chemo
Chemo increases immunogenicity, depletes immunosuppressive Tregs (CD3-targeting BiTEs recruit polyclonal T cells, including Tregs)
NCT05365581: ASP2138 (CD3 x CLDN18.2) ± chemo
27/31 #TumorBoardTuesday
Back to our case🔎
Enrolled in CD3 x CLDN18.2 BiTE trial
At 1 month, SD by CT but rising CA19-9 (206 -> 791)
Back to our case🔎
Enrolled in CD3 x CLDN18.2 BiTE trial
At 1 month, SD by CT but rising CA19-9 (206 -> 791)
February 5, 2025 at 1:54 AM
27/31 #TumorBoardTuesday
Back to our case🔎
Enrolled in CD3 x CLDN18.2 BiTE trial
At 1 month, SD by CT but rising CA19-9 (206 -> 791)
Back to our case🔎
Enrolled in CD3 x CLDN18.2 BiTE trial
At 1 month, SD by CT but rising CA19-9 (206 -> 791)
26/31 #TumorBoardTuesday
🏫Mini Tutorial 23🏫
58% panc pts had ≥3 prior lines
PC: ORR 16.7%, mDOR 3.4 mos, CBR 33.3%
At dose level 3, 2/5 PR in panc pts
CRS mostly grade 1-2, 2 cases grade 3
ICANS grade 1 in 2 pts
🏫Mini Tutorial 23🏫
58% panc pts had ≥3 prior lines
PC: ORR 16.7%, mDOR 3.4 mos, CBR 33.3%
At dose level 3, 2/5 PR in panc pts
CRS mostly grade 1-2, 2 cases grade 3
ICANS grade 1 in 2 pts
February 5, 2025 at 1:52 AM
26/31 #TumorBoardTuesday
🏫Mini Tutorial 23🏫
58% panc pts had ≥3 prior lines
PC: ORR 16.7%, mDOR 3.4 mos, CBR 33.3%
At dose level 3, 2/5 PR in panc pts
CRS mostly grade 1-2, 2 cases grade 3
ICANS grade 1 in 2 pts
🏫Mini Tutorial 23🏫
58% panc pts had ≥3 prior lines
PC: ORR 16.7%, mDOR 3.4 mos, CBR 33.3%
At dose level 3, 2/5 PR in panc pts
CRS mostly grade 1-2, 2 cases grade 3
ICANS grade 1 in 2 pts
25/31 #TumorBoardTuesday
🏫Mini Tutorial 22🏫
2) Phase 1b/2, CT041 in CLDN18.2+ adv gastric or panc (ELIMYN18.2, NCT04404595)
19 patients: 7 gastric/GEJ cancer, 12 pancreatic cancer
doi.org/10.1200/JCO.2024.42.3_suppl.356
🏫Mini Tutorial 22🏫
2) Phase 1b/2, CT041 in CLDN18.2+ adv gastric or panc (ELIMYN18.2, NCT04404595)
19 patients: 7 gastric/GEJ cancer, 12 pancreatic cancer
doi.org/10.1200/JCO.2024.42.3_suppl.356
February 5, 2025 at 1:52 AM
25/31 #TumorBoardTuesday
🏫Mini Tutorial 22🏫
2) Phase 1b/2, CT041 in CLDN18.2+ adv gastric or panc (ELIMYN18.2, NCT04404595)
19 patients: 7 gastric/GEJ cancer, 12 pancreatic cancer
doi.org/10.1200/JCO.2024.42.3_suppl.356
🏫Mini Tutorial 22🏫
2) Phase 1b/2, CT041 in CLDN18.2+ adv gastric or panc (ELIMYN18.2, NCT04404595)
19 patients: 7 gastric/GEJ cancer, 12 pancreatic cancer
doi.org/10.1200/JCO.2024.42.3_suppl.356
24/31 #TumorBoardTuesday
🏫Mini Tutorial 21🏫
Pooled analysis of CT041 in met panc (NCT03874897, NCT04581473)
24 pts with advanced panc
ORR 16.7%, DCR 70.8%
mPFS 3.3 mos, mOS 10 mos
mDOR 9.5 mos, DOR 50% at 12 mos
AEs: CRS, GI
doi.org/10.1200/JCO.23.02314
🏫Mini Tutorial 21🏫
Pooled analysis of CT041 in met panc (NCT03874897, NCT04581473)
24 pts with advanced panc
ORR 16.7%, DCR 70.8%
mPFS 3.3 mos, mOS 10 mos
mDOR 9.5 mos, DOR 50% at 12 mos
AEs: CRS, GI
doi.org/10.1200/JCO.23.02314
February 5, 2025 at 1:51 AM
24/31 #TumorBoardTuesday
🏫Mini Tutorial 21🏫
Pooled analysis of CT041 in met panc (NCT03874897, NCT04581473)
24 pts with advanced panc
ORR 16.7%, DCR 70.8%
mPFS 3.3 mos, mOS 10 mos
mDOR 9.5 mos, DOR 50% at 12 mos
AEs: CRS, GI
doi.org/10.1200/JCO.23.02314
🏫Mini Tutorial 21🏫
Pooled analysis of CT041 in met panc (NCT03874897, NCT04581473)
24 pts with advanced panc
ORR 16.7%, DCR 70.8%
mPFS 3.3 mos, mOS 10 mos
mDOR 9.5 mos, DOR 50% at 12 mos
AEs: CRS, GI
doi.org/10.1200/JCO.23.02314
23/31 #TumorBoardTuesday
🏫Mini Tutorial 20🏫
96.9% CRS, all grade 1-2
8% gastric mucosal injury, 1 pt w/ grade 3
No DLTs, treatment related deaths, ICANS
🏫Mini Tutorial 20🏫
96.9% CRS, all grade 1-2
8% gastric mucosal injury, 1 pt w/ grade 3
No DLTs, treatment related deaths, ICANS
February 5, 2025 at 1:48 AM
23/31 #TumorBoardTuesday
🏫Mini Tutorial 20🏫
96.9% CRS, all grade 1-2
8% gastric mucosal injury, 1 pt w/ grade 3
No DLTs, treatment related deaths, ICANS
🏫Mini Tutorial 20🏫
96.9% CRS, all grade 1-2
8% gastric mucosal injury, 1 pt w/ grade 3
No DLTs, treatment related deaths, ICANS
22/31 #TumorBoardTuesday
🏫Mini Tutorial 19🏫
ORR 38.8%, DCR 91.8%, mDOR 6.4 mos
Among 10 pts with PDAC: 2 PR, 7 SD, 1 PD
doi.org/10.1038/s41591-024-03037-z
🏫Mini Tutorial 19🏫
ORR 38.8%, DCR 91.8%, mDOR 6.4 mos
Among 10 pts with PDAC: 2 PR, 7 SD, 1 PD
doi.org/10.1038/s41591-024-03037-z
February 5, 2025 at 1:47 AM
22/31 #TumorBoardTuesday
🏫Mini Tutorial 19🏫
ORR 38.8%, DCR 91.8%, mDOR 6.4 mos
Among 10 pts with PDAC: 2 PR, 7 SD, 1 PD
doi.org/10.1038/s41591-024-03037-z
🏫Mini Tutorial 19🏫
ORR 38.8%, DCR 91.8%, mDOR 6.4 mos
Among 10 pts with PDAC: 2 PR, 7 SD, 1 PD
doi.org/10.1038/s41591-024-03037-z
21/31 #TumorBoardTuesday
🏫Mini Tutorial 18🏫
CLDN18.2 CAR-T Trials:
1) Phase 1, CT041 (CLDN18.2 CAR-T) in CLDN18.2+ adv GI cancers (NCT03874897)
AKA satricabtagene autoleucel (satri-cel)
98 pts got CT041: 75% gastric/GEJ, 10% panc, 8% intestinal, 4% BTC
🏫Mini Tutorial 18🏫
CLDN18.2 CAR-T Trials:
1) Phase 1, CT041 (CLDN18.2 CAR-T) in CLDN18.2+ adv GI cancers (NCT03874897)
AKA satricabtagene autoleucel (satri-cel)
98 pts got CT041: 75% gastric/GEJ, 10% panc, 8% intestinal, 4% BTC
February 5, 2025 at 1:46 AM
21/31 #TumorBoardTuesday
🏫Mini Tutorial 18🏫
CLDN18.2 CAR-T Trials:
1) Phase 1, CT041 (CLDN18.2 CAR-T) in CLDN18.2+ adv GI cancers (NCT03874897)
AKA satricabtagene autoleucel (satri-cel)
98 pts got CT041: 75% gastric/GEJ, 10% panc, 8% intestinal, 4% BTC
🏫Mini Tutorial 18🏫
CLDN18.2 CAR-T Trials:
1) Phase 1, CT041 (CLDN18.2 CAR-T) in CLDN18.2+ adv GI cancers (NCT03874897)
AKA satricabtagene autoleucel (satri-cel)
98 pts got CT041: 75% gastric/GEJ, 10% panc, 8% intestinal, 4% BTC
20/31 #TumorBoardTuesday
🏫Mini Tutorial 17🏫
5) Phase 1/2, PT886 (CD47 x CLDN18.2 bispecific) in adv gastric/GEJ or PC (TWINPEAK, NCT05482893)
Promotes ADCC by NK cells, phagocytosis by macrophages
Part C, cohort 2: 1L adv PDAC w/ CLDN18.2 ≥2+ ≥10%, PT886 + chemo
Results pending
🏫Mini Tutorial 17🏫
5) Phase 1/2, PT886 (CD47 x CLDN18.2 bispecific) in adv gastric/GEJ or PC (TWINPEAK, NCT05482893)
Promotes ADCC by NK cells, phagocytosis by macrophages
Part C, cohort 2: 1L adv PDAC w/ CLDN18.2 ≥2+ ≥10%, PT886 + chemo
Results pending
February 5, 2025 at 1:45 AM
20/31 #TumorBoardTuesday
🏫Mini Tutorial 17🏫
5) Phase 1/2, PT886 (CD47 x CLDN18.2 bispecific) in adv gastric/GEJ or PC (TWINPEAK, NCT05482893)
Promotes ADCC by NK cells, phagocytosis by macrophages
Part C, cohort 2: 1L adv PDAC w/ CLDN18.2 ≥2+ ≥10%, PT886 + chemo
Results pending
🏫Mini Tutorial 17🏫
5) Phase 1/2, PT886 (CD47 x CLDN18.2 bispecific) in adv gastric/GEJ or PC (TWINPEAK, NCT05482893)
Promotes ADCC by NK cells, phagocytosis by macrophages
Part C, cohort 2: 1L adv PDAC w/ CLDN18.2 ≥2+ ≥10%, PT886 + chemo
Results pending
19/31 #TumorBoardTuesday
Mini Tutorial 16
4) Phase 1/2, PM1032 (CLDN18.2 x 41BB bispecific) in adv solid tumors (NCT05839106)
Activates T and NK cells
30 patients, no DLTs, 66.7% CLDN18.2+
14 gastric/GEJ, 10 panc, 5 other GI
17 CLDN18.2+ pts at ≥5 mg/kg: 2 PR, 7 SD
Mini Tutorial 16
4) Phase 1/2, PM1032 (CLDN18.2 x 41BB bispecific) in adv solid tumors (NCT05839106)
Activates T and NK cells
30 patients, no DLTs, 66.7% CLDN18.2+
14 gastric/GEJ, 10 panc, 5 other GI
17 CLDN18.2+ pts at ≥5 mg/kg: 2 PR, 7 SD
February 5, 2025 at 1:43 AM
19/31 #TumorBoardTuesday
Mini Tutorial 16
4) Phase 1/2, PM1032 (CLDN18.2 x 41BB bispecific) in adv solid tumors (NCT05839106)
Activates T and NK cells
30 patients, no DLTs, 66.7% CLDN18.2+
14 gastric/GEJ, 10 panc, 5 other GI
17 CLDN18.2+ pts at ≥5 mg/kg: 2 PR, 7 SD
Mini Tutorial 16
4) Phase 1/2, PM1032 (CLDN18.2 x 41BB bispecific) in adv solid tumors (NCT05839106)
Activates T and NK cells
30 patients, no DLTs, 66.7% CLDN18.2+
14 gastric/GEJ, 10 panc, 5 other GI
17 CLDN18.2+ pts at ≥5 mg/kg: 2 PR, 7 SD
18/31 #TumorBoardTuesday
🏫Mini Tutorial 15🏫
Efficacy for 600 µg/kg in CLDN18.2 IHC 2+/3+ ≥10%:
27 pts, 8 PRs, 11 SDs, ORR 39.6%, DCR 70.4%
DOR and PFS not reached
🏫Mini Tutorial 15🏫
Efficacy for 600 µg/kg in CLDN18.2 IHC 2+/3+ ≥10%:
27 pts, 8 PRs, 11 SDs, ORR 39.6%, DCR 70.4%
DOR and PFS not reached
February 5, 2025 at 1:41 AM
18/31 #TumorBoardTuesday
🏫Mini Tutorial 15🏫
Efficacy for 600 µg/kg in CLDN18.2 IHC 2+/3+ ≥10%:
27 pts, 8 PRs, 11 SDs, ORR 39.6%, DCR 70.4%
DOR and PFS not reached
🏫Mini Tutorial 15🏫
Efficacy for 600 µg/kg in CLDN18.2 IHC 2+/3+ ≥10%:
27 pts, 8 PRs, 11 SDs, ORR 39.6%, DCR 70.4%
DOR and PFS not reached
17/31 #TumorBoardTuesday
🏫Mini Tutorial 14🏫
3) Phase 1, IBI389 (CLDN18.2 x CD3) in adv PDAC (NCT05164458)
64 patients, median 2 prior lines
54.7% G3+ TRAEs: GGT increased, lymphs decreased, nausea
51.6% CRS, no grade 3+
TEAEs -> dose interruption 37.5%, discontinuation 4.7%
🏫Mini Tutorial 14🏫
3) Phase 1, IBI389 (CLDN18.2 x CD3) in adv PDAC (NCT05164458)
64 patients, median 2 prior lines
54.7% G3+ TRAEs: GGT increased, lymphs decreased, nausea
51.6% CRS, no grade 3+
TEAEs -> dose interruption 37.5%, discontinuation 4.7%
February 5, 2025 at 1:38 AM
17/31 #TumorBoardTuesday
🏫Mini Tutorial 14🏫
3) Phase 1, IBI389 (CLDN18.2 x CD3) in adv PDAC (NCT05164458)
64 patients, median 2 prior lines
54.7% G3+ TRAEs: GGT increased, lymphs decreased, nausea
51.6% CRS, no grade 3+
TEAEs -> dose interruption 37.5%, discontinuation 4.7%
🏫Mini Tutorial 14🏫
3) Phase 1, IBI389 (CLDN18.2 x CD3) in adv PDAC (NCT05164458)
64 patients, median 2 prior lines
54.7% G3+ TRAEs: GGT increased, lymphs decreased, nausea
51.6% CRS, no grade 3+
TEAEs -> dose interruption 37.5%, discontinuation 4.7%
16/31 #TumorBoardTuesday
🏫Mini Tutorial 13🏫
2) Phase 1, ASP2138 (CD3 x CLDN18.2 BiTE) ± chemo in CLDN18.2+ adv gastric/GEJ or PC (NCT05365581)
2+1: 2 CLDN18.2 binding sites, 1 CD3 binding site
🏫Mini Tutorial 13🏫
2) Phase 1, ASP2138 (CD3 x CLDN18.2 BiTE) ± chemo in CLDN18.2+ adv gastric/GEJ or PC (NCT05365581)
2+1: 2 CLDN18.2 binding sites, 1 CD3 binding site
February 5, 2025 at 1:37 AM
16/31 #TumorBoardTuesday
🏫Mini Tutorial 13🏫
2) Phase 1, ASP2138 (CD3 x CLDN18.2 BiTE) ± chemo in CLDN18.2+ adv gastric/GEJ or PC (NCT05365581)
2+1: 2 CLDN18.2 binding sites, 1 CD3 binding site
🏫Mini Tutorial 13🏫
2) Phase 1, ASP2138 (CD3 x CLDN18.2 BiTE) ± chemo in CLDN18.2+ adv gastric/GEJ or PC (NCT05365581)
2+1: 2 CLDN18.2 binding sites, 1 CD3 binding site
15/31 #TumorBoardTuesday
🏫Mini Tutorial 12🏫
CLDN18.2 bispecific trials:
1) Phase 1, Q-1802 (PD-L1 x CLDN18.2) (NCT04856150)
17 pts w/ adv gastric, PC, or BTC, mostly ≥3 prior lines
2/9 PRs, 4/9 SDs
AEs: n/v, abd pain, GERD
24.1% G3 TRAEs
doi.org/10.1200/JCO.2023.41.4_suppl.382
🏫Mini Tutorial 12🏫
CLDN18.2 bispecific trials:
1) Phase 1, Q-1802 (PD-L1 x CLDN18.2) (NCT04856150)
17 pts w/ adv gastric, PC, or BTC, mostly ≥3 prior lines
2/9 PRs, 4/9 SDs
AEs: n/v, abd pain, GERD
24.1% G3 TRAEs
doi.org/10.1200/JCO.2023.41.4_suppl.382
February 5, 2025 at 1:35 AM
15/31 #TumorBoardTuesday
🏫Mini Tutorial 12🏫
CLDN18.2 bispecific trials:
1) Phase 1, Q-1802 (PD-L1 x CLDN18.2) (NCT04856150)
17 pts w/ adv gastric, PC, or BTC, mostly ≥3 prior lines
2/9 PRs, 4/9 SDs
AEs: n/v, abd pain, GERD
24.1% G3 TRAEs
doi.org/10.1200/JCO.2023.41.4_suppl.382
🏫Mini Tutorial 12🏫
CLDN18.2 bispecific trials:
1) Phase 1, Q-1802 (PD-L1 x CLDN18.2) (NCT04856150)
17 pts w/ adv gastric, PC, or BTC, mostly ≥3 prior lines
2/9 PRs, 4/9 SDs
AEs: n/v, abd pain, GERD
24.1% G3 TRAEs
doi.org/10.1200/JCO.2023.41.4_suppl.382
14/31 #TumorBoardTuesday
🏫Mini Tutorial 11🏫
CLDN18.2 IHC 1+/2+/3+ ≥40%: ORR 28% (all PRs: 5 PDAC, 2 BTC), DCR 80%
CLDN18.2 ≥60%: ORR 38.5% (all PRs: 4 PDAC, 1 BTC), DCR 84.6%
25.7% G3+ TRAEs: anemia, neutropenia, elevated AST
Dose interruption 20%, discontinuation 2.9%
🏫Mini Tutorial 11🏫
CLDN18.2 IHC 1+/2+/3+ ≥40%: ORR 28% (all PRs: 5 PDAC, 2 BTC), DCR 80%
CLDN18.2 ≥60%: ORR 38.5% (all PRs: 4 PDAC, 1 BTC), DCR 84.6%
25.7% G3+ TRAEs: anemia, neutropenia, elevated AST
Dose interruption 20%, discontinuation 2.9%
February 5, 2025 at 1:33 AM
14/31 #TumorBoardTuesday
🏫Mini Tutorial 11🏫
CLDN18.2 IHC 1+/2+/3+ ≥40%: ORR 28% (all PRs: 5 PDAC, 2 BTC), DCR 80%
CLDN18.2 ≥60%: ORR 38.5% (all PRs: 4 PDAC, 1 BTC), DCR 84.6%
25.7% G3+ TRAEs: anemia, neutropenia, elevated AST
Dose interruption 20%, discontinuation 2.9%
🏫Mini Tutorial 11🏫
CLDN18.2 IHC 1+/2+/3+ ≥40%: ORR 28% (all PRs: 5 PDAC, 2 BTC), DCR 80%
CLDN18.2 ≥60%: ORR 38.5% (all PRs: 4 PDAC, 1 BTC), DCR 84.6%
25.7% G3+ TRAEs: anemia, neutropenia, elevated AST
Dose interruption 20%, discontinuation 2.9%
13/31 #TumorBoardTuesday
🏫Mini Tutorial 10🏫
2) Phase 1, IBI343 (CLDN18.2 ADC w/ exatecan) in PDAC or BTC (NCT05458219)
35 patients enrolled: 28 PDAC, 7 BTC (all pretreated)
Dose expansion: CLDN18.2 IHC 1+/2+/3+ ≥40%
doi.org/10.1200/JCO.2024.42.16_suppl.3037
🏫Mini Tutorial 10🏫
2) Phase 1, IBI343 (CLDN18.2 ADC w/ exatecan) in PDAC or BTC (NCT05458219)
35 patients enrolled: 28 PDAC, 7 BTC (all pretreated)
Dose expansion: CLDN18.2 IHC 1+/2+/3+ ≥40%
doi.org/10.1200/JCO.2024.42.16_suppl.3037
February 5, 2025 at 1:31 AM
13/31 #TumorBoardTuesday
🏫Mini Tutorial 10🏫
2) Phase 1, IBI343 (CLDN18.2 ADC w/ exatecan) in PDAC or BTC (NCT05458219)
35 patients enrolled: 28 PDAC, 7 BTC (all pretreated)
Dose expansion: CLDN18.2 IHC 1+/2+/3+ ≥40%
doi.org/10.1200/JCO.2024.42.16_suppl.3037
🏫Mini Tutorial 10🏫
2) Phase 1, IBI343 (CLDN18.2 ADC w/ exatecan) in PDAC or BTC (NCT05458219)
35 patients enrolled: 28 PDAC, 7 BTC (all pretreated)
Dose expansion: CLDN18.2 IHC 1+/2+/3+ ≥40%
doi.org/10.1200/JCO.2024.42.16_suppl.3037