CTX-471 + Pembrolizumab for Cancer

Recruiting at 9 trial locations

Overseen By Natalie Warholic

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Compass Therapeutics

Must be taking: PD-1 or PD-L1 inhibitors

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Autoimmune disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

100 Participants Needed

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.

Research Team

Thomas Scheutz, MD, PhD

Principal Investigator

Compass Therapeutics

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CTX-471 as a monotherapy or in combination with pembrolizumab, with dose escalation and expansion phases

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CTX-471
• Pembrolizumab

Trial Overview 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).

Participant Groups

Group I: Arm 2 Part 2 Dose Expansion Experimental Treatment 2 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 Escalation Experimental Treatment 2 Interventions

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

Group III: Arm 1 Part 2 Dose Expansion Experimental Treatment 1 Intervention

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

Group IV: Arm 1 Part 1 Dose Escalation Experimental Treatment 1 Intervention

Escalating doses of CTX-471 depending on cohort at enrollment

Who Is Running the Clinical Trial?

Compass Therapeutics

Lead Sponsor

Trials

5

Recruited

430+

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD

Merck, Sharp & Dohme, LLC, Rahway, NJ USA

Collaborator

Trials

1

Recruited

100+