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Monoclonal Antibodies

HMBD-002 + Pembrolizumab for Cancer

Phase 1

Recruiting

Research Sponsored by Hummingbird Bioscience, Inc.

Eligibility Criteria Checklist

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

Must have

Triple Negative Breast Cancer (TNBC): Histologic or cytologic evidence of TNBC that is advanced or metastatic. Will be requested to undergo a tumor biopsy before treatment and after 6 weeks of treatment. Must have received appropriate treatment with at least one prior regimen for TNBC and there are no available therapies known to confer clinical benefit

At least 18 years old

Must not have

A positive status for human immunodeficiency virus (HIV)

Presence of uncontrolled, clinically significant pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of dosing through every 90 after the last dose.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, HMBD-002, on patients with advanced solid tumors. The drug will be administered intravenously, and the trial will have two parts: dose escalation and dose expansion.

Who is the study for?

Adults with advanced solid tumors, including specific types of breast and lung cancer without available beneficial therapies. Participants must have measurable disease, be at least 18 years old with good performance status and organ function, agree to contraception, and provide informed consent. Excludes those with certain infections or immune conditions, recent high-dose radiotherapy to the lungs, severe treatment-related adverse events from similar drugs, uncontrolled diseases or other active cancers.

What is being tested?

The trial is testing HMBD-002 alone or combined with Pembrolizumab in patients with various advanced solid tumors. It's a two-part study: first finding the right dose (dose escalation) then expanding that dose to more patients (dose expansion). The treatments are given intravenously on different schedules.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in organs; infusion-related reactions; fatigue; changes in blood counts which can affect overall health; increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I have advanced or metastatic TNBC and have tried at least one treatment with no success.

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I am 18 years old or older.

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My cancer is advanced or has spread, and there are no treatments left that could help.

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I can carry out all my usual activities without help.

Exclusion Criteria

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

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I am HIV positive.

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

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I had radiotherapy less than 2 weeks ago.

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I have not received a live vaccine in the last 30 days.

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I have had lung inflammation or disease that needed steroids.

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I stopped a cancer treatment due to a severe immune reaction.

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I have been treated with a VISTA targeting agent.

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I am not on high-dose steroids or other drugs that weaken my immune system.

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I have not had any other cancer that is getting worse or needed treatment in the last 3 years.

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I have cancer that has spread to my brain or spinal cord.

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I have a hormone disorder that is not under control.

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I have a history of Hepatitis B or active Hepatitis C.

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I have received a transplant from another person.

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I have had radiation to my lung of more than 30 Gray in the last 6 months.

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I need oxygen support to breathe.

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I do not have any other illnesses that would stop me from following the study's requirements.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of dosing through every 90 after the last dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of dosing through every 90 after the last dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of dosing through every 90 after the last dose. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-Finding

Dose-limiting Toxicity

Frequency and Severity of Adverse Events (AE)

Secondary study objectives

Duration of Response (DoR)

Objective Response Rate (ORR)

Overall Survival (OS)

+2 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: Part 2 - Dose Expansion (Monotherapy)Experimental Treatment1 Intervention

HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion as a monotherapy in patients with TNBC or NSCLC.

Group II: Part 2 - Dose Expansion (Combination Therapy)Experimental Treatment2 Interventions

HMBD-002 administered at the MTD/RP2D as a 60-minute IV infusion in combination with pembrolizumab KEYTRUDA® at the standard labeled dose in patients with TNBC or NSCLC.

Group III: Part 1 - Dose Escalation Phase (Monotherapy)Experimental Treatment1 Intervention

HMBD-002 administered as a 60-minute IV infusion as a monotherapy. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle.

Group IV: Part 1 - Dose Escalation Phase (Combination Therapy)Experimental Treatment2 Interventions

HMBD-002 administered as a 60-minute IV infusion at escalating doses in combination with pembrolizumab KEYTRUDA®. HMBD-002 will be administered on Days 1, 8, and 15 of a 21-day cycle. The treatment pembrolizumab KEYTRUDA® will be administered as a 30-minute IV infusion at a dose of 200 mg on Day 1 of every 21-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 21Eligibility criteria met