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BXCL701

Phase 2

Metastatic Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |BioXcel Therapeutics, Inc.|Last Updated: Feb 12, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment22

FDA Designations

FAST_TRACKORPHAN_DRUG

Clinical trial landscape

BXCL701 · 1 trial · 1 indication

Phase 2 1
NCT05558982BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Ductal Adenocarcinoma
ACTIVE NOT_RECRUITING22 Analytics
PHASE2ACTIVE NOT_RECRUITING
BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival at 18 weeks
18 weeks

Secondary Endpoints

Incidence of Adverse events
From start of intervention until 30 days following discontinuation of intervention
Objective response rate
Through study completion, on average 18 weeks
Median Duration of response (DOR)
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BXCL701 plus PembrolizumabEXPERIMENTAL -

Interventions

NameTypeDescription
BXCL701DRUGBXCL701 0.3 mg, orally, twice a day on days 1-14 every 21 days
PembrolizumabDRUGPembrolizumab 200 mg intravenous (IV) on day 1 every 21 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically-confirmed pancreatic ductal adenocarcinoma with metastatic disease (mixed histology is acceptable as long adenocarcinoma is the dominant histological subtype) * Patient must consent to two mandatory biopsies and have tumor amenable to serial core biopsies * Meas...

Countries:United States
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Frequently asked questions about BXCL701

What is BXCL701 used for?

BXCL701 is an investigational small molecule being studied for the treatment of metastatic pancreatic ductal adenocarcinoma and prostate cancer. It is currently in Phase 2 clinical development for these oncology indications.

What does BXCL701 target?

BXCL701 is a small molecule being developed for oncology indications. Its specific molecular target has not been disclosed in available information.

Who makes BXCL701?

BXCL701 is being developed by BioXcel Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol BTAI.

What phase is BXCL701 in?

BXCL701 is in Phase 2 clinical development. It has received Fast Track and Orphan Drug designations from the FDA for its oncology indications.

What clinical trials is BXCL701 in?

BXCL701 is being studied in two clinical trials. NCT03910660 is a completed Phase 1 trial combining BXCL701 with pembrolizumab in prostate cancer. NCT05558982 is an active Phase 2 trial of BXCL701 with pembrolizumab in metastatic pancreatic ductal adenocarcinoma.

Is BXCL701 FDA approved?

BXCL701 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for metastatic pancreatic ductal adenocarcinoma and prostate cancer.