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Monoclonal Antibodies

CTX-471 + Pembrolizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by Compass Therapeutics

Eligibility Criteria Checklist

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

Must have

Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control for the duration of the study and for 4 months following the last dose of study treatment

Willingness to provide pre- and post-treatment fresh tumor biopsies for Monotherapy Arm 1

Must not have

Has had an allogeneic tissue transplant for Combination Arm 2

Has an active infection requiring systemic therapy for Combination Arm 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline until confirmed disease progression (cr or pr) (up to 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a drug (CTX-471) alone or with pembrolizumab to treat cancer that has not responded to PD-1/PD-L1 inhibitor drugs. Two parts of the trial will assess different doses.

Who is the study for?

Adults with certain advanced cancers (like lung, melanoma, or head and neck) that worsened after PD-1/PD-L1 inhibitor treatment can join. They must have good organ function, no recent immunosuppressants or vaccines, not be pregnant or breastfeeding, and agree to use birth control. Excluded are those with severe heart issues, active infections like hepatitis B/C or HIV unless controlled, other recent cancer treatments or live vaccines.

What is being tested?

The trial is testing CTX-471 alone or with pembrolizumab in patients whose cancer progressed on PD-1/PD-L1 inhibitors. It's a Phase 1 study with two parts: first finding the right dose (escalation), then expanding to more patients at that dose (expansion).

What are the potential side effects?

Possible side effects include reactions related to the immune system since both drugs work by boosting it. This could lead to inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue from the body's increased activity fighting cancer cells.

Eligibility Criteria

Inclusion Criteria

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

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I am a male either sterile or will use birth control during and 4 months after the study.

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I am willing to give fresh tumor samples before and after treatment for a study.

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I am fully active or can carry out light work.

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I have signed the consent form for this study.

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My cancer progressed after treatment with a PD-1 or PD-L1 inhibitor.

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My blood tests show enough white cells, platelets, and hemoglobin.

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I am 18 years old or older.

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My kidneys work well enough, with a creatinine clearance over 30 mL/min.

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My cancer is confirmed as advanced and falls under specific types.

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I am a woman who can have children and have a recent negative pregnancy test.

Exclusion Criteria

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

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I have received a tissue transplant from another person for my treatment.

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I am currently on medication for an active infection.

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I have or had lung inflammation that needed steroids.

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I stopped PD-1 or PD-L1 therapy due to a severe side effect.

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I haven't taken immunosuppressive drugs in the last 7 days.

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I do not have active heart issues like recent heart failure, new chest pain, or irregular heartbeats.

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My cancer has spread to my brain.

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I haven't had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.

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I have an autoimmune disease or need long-term steroids or immune-suppressing drugs.

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I have active brain metastases or carcinomatous meningitis.

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I have another cancer besides the one being treated, which has progressed or needed treatment in the last 3 years.

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I have a history of seizures.

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I have had a solid organ transplant.

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I am HIV positive, on ART, and my HIV is well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until confirmed disease progression (cr or pr) (up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until confirmed disease progression (cr or pr) (up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until confirmed disease progression (cr or pr) (up to 2 years) for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 of CTX-471 as a monotherapy and CTX-471 in combination with pembrolizumab

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: Arm 2 Part 2 Dose ExpansionExperimental Treatment2 Interventions

Two cohorts of CTX-471 (0.3 mg/kg and 0.6 mg/kg) in combination with pembrolizumab (KEYTRUDA® ) (400 mg) in three tumor type subgroups. Cohort 1 - Group 1A - NSCLC , Group 1B -SCLC and Group 1C - Melanoma. Cohort 2 Group 2A - NSCLC, Group 2B - SCLC and Group 2C -Melanoma.

Group II: Arm 2 Part 1 Dose EscalationExperimental Treatment2 Interventions

Escalating doses of CTX-471 in combination with pembrolizumab (KEYTRUDA® ) depending on cohort at enrollment

Group III: Arm 1 Part 2 Dose ExpansionExperimental Treatment1 Intervention

Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg)

Group IV: Arm 1 Part 1 Dose EscalationExperimental Treatment1 Intervention

Escalating doses of CTX-471 depending on cohort at enrollment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab (KEYTRUDA®)

2017