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Immunomodulator

BXCL701 + Pembrolizumab for Prostate Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by BioXcel Therapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has evidence of progressive, metastatic castration-resistant disease, as defined by PCWG3 criteria

Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patient has brain or leptomeningeal metastases that are symptomatic and progressive on imaging

Patient has known positive status for human immunodeficiency virus, active or chronic Hepatitis B, or Hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug combination to treat advanced prostate cancer, to identify the recommended dose, and to assess its effectiveness and safety.

Who is the study for?

This trial is for men with advanced prostate cancer that's resistant to hormone therapy and has spread. Participants must have either small cell neuroendocrine cancer or adenocarcinoma, be willing to undergo a biopsy, and have received prior chemotherapy. They should not have other active cancers or certain heart conditions, and can't have had recent treatments that could interfere with the study.

What is being tested?

The trial is testing BXCL701 alone and combined with Pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC). It aims to find the best dose, check how well it works, and monitor safety. The study includes multiple phases where different patient groups are treated based on their type of cancer.

What are the potential side effects?

Potential side effects may include immune system reactions since Pembrolizumab targets PD-1/PD-L1 pathways involved in immune response. BXCL701 could cause digestive issues as it's taken orally. Both drugs might lead to fatigue, skin reactions, changes in blood tests or inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is spreading despite hormone therapy.

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I am able to get out of my bed or chair and move around.

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My cancer diagnosis was confirmed with a biopsy.

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My side effects from cancer treatment are mild, except for possible nerve pain or hair loss.

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I am 18 years old or older.

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My blood counts are within a healthy range.

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I've had 1-2 treatments targeting the AR pathway and one chemotherapy for my prostate cancer.

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I am willing to have a biopsy of my cancer that has spread.

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My prostate cancer is confirmed and does not have small cell features.

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I have had chemotherapy before.

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My prostate cancer has worsened despite having at least one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or its coverings and is getting worse.

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I have HIV, Hepatitis B, or Hepatitis C.

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I have been treated with specific immune system drugs or need treatment with DPP4 inhibitors.

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I don't have swallowing issues or severe diarrhea that could affect medication absorption.

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I do not have any uncontrolled illnesses or situations that would stop me from following the study rules.

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I have another active cancer that could affect the study's results.

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I have had dizziness or fainting when standing up in the last 3 months.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have a serious heart condition.

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I have had more than two chemotherapy treatments for advanced prostate cancer.

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I have a serious lung condition that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 2a: Estimate the composite response rate of the combination of BXCL701 + PEMBRO

Phase 2b: Evaluate response rates in patients treated with the combination of BXCL701 + PEMBRO and with BXCL701 monotherapy

Secondary study objectives

Phase 2a: Assess pharmacodynamic profile of BXCL701 and Pembro

Phase 2a: Assess population pK of BXCL701

Phase 2a: Determine the risk profile of the use of BXCL701 in combination with PEMBRO.

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2b monotherapyExperimental Treatment1 Intervention

Upon completion of the Phase 2a and achievement of the protocol required composite responses for a given histologic subtype, the Phase 2b enrollment will begin for that subtype. Eligible patients will be randomized to receive: * Monotherapy BXCL701 on Days 1 to 14 of a 21-day cycle. Upon radiographic disease progression with monotherapy, crossover to combination treatment is allowed.

Group II: Phase 2b combinationExperimental Treatment1 Intervention

Upon completion of the Phase 2a and achievement of the protocol required composite responses for a given histologic subtype, the Phase 2b enrollment will begin for that subtype. Eligible patients will be randomized to receive: • Combination therapy of BXCL701 on Days 1 to 14 of a 21-day cycle plus PEMBRO 200 mg administered IV on Day 1 of every 21 days.

Group III: Phase 2aExperimental Treatment1 Intervention

After assessment of the safety and confirmation of the BXCL701/+PEMBRO dose schedule to be used in the subsequent stage, the Phase 2a will begin. Eligible patients will receive BXCL701 QD on Days 1 to 14 of a 21-day cycle plus PEMBRO 200 mg administered IV on Day 1 every 21 days.

Group IV: Phase 1bExperimental Treatment1 Intervention

Patients will be observed for dose-limiting toxicity (DLT) during Cycle 1. 3 patients will be treated initially with 0.4 mg BXCL701 plus PEMBRO: If there are no DLTs, the dose of BXCL701 will be escalated to 0.6 mg in the next cohort. If ≥1/3 of patients has a DLT in Cycle 1, either 3 patients (if 1 experience a DLT) or 6 to 9 patients (if 2 or 3 experiences a DLT) will be added at the 0.4 mg dose. At the 0.4mg dose: If \<1/3 of the patients experience a DLT, consideration will be given to dose to 0.6 mg BXCL701 plus PEMBRO. If 1/3 of the patients experience a DLT, the Phase 2a can commence. If \>1/3 of the patients experience a DLT, a discussion will be held as to how to proceed. Following 0.6 mg dose. If there are no DLTs, the Phase 2a can commence. If ≥1/3 patients have a DLT in Cycle 1, after a discussion, 6 to 9 patients will be added at the 0.6 mg dose. For this cohort of 6 to 9 patients: If \</=1/3 of the patients experience a DLT, the Phase 2a can commence

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