CTX-471 + Pembrolizumab for Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Compass Therapeutics

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.

Eligibility Criteria

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.

Inclusion Criteria

My liver is functioning well according to recent blood tests.

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

It's been over 28 days since my last PD-1/PD-L1 therapy, and over 21 days since any cancer treatment, radiotherapy, or surgery.

+15 more

Exclusion Criteria

I've had lung radiation over 30Gy within the last 6 months for a specific treatment.

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

I am currently on medication for an active infection.

+23 more

Participant Groups

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).

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