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A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

ConditionsNon Small Cell Lung CancerTriple Negative Breast CancerHodgkin LymphomaHead and Neck Squamous Cell CarcinomaMalignant Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCompass Therapeutics

About this trial

This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including

Malignant Melanoma (MM)

Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody

Disqualifiers

Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment

Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed

Patient is a pregnant or lactating WOCBP

Prior organ transplantation

Trial design

Design model

Sequential

Treatments tested in this trial

  • CTX-8371

    Drug

    Intravenous (IV) infusion every two weeks.

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Dose Escalation Cohort 1Experimental treatment 1 intervention
Group B: Dose Expansion Cohort 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371

Number of participants with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities

Time frame
From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371, average of 6 months
2

Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in Cohort 2 and Phase 2 studies

Time frame
From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks ) until 30 days after the last dose of CTX-8371 (average of 6 months )
3

Cohort 2: Evaluate the safety and tolerability of CTX-8371 at 3.0 mg/kg and 10.0 mg/kg

Incidence of treatment-emergent adverse events (TEAEs)

Time frame
From first dose of CTX-8371 (Cycle 1 Day 1, Cycle = 2 weeks) until 30 days after the last dose of CTX-8371 (up to 2 years)

Secondary outcomes

1

Cohort 1 and 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Time frame
Baseline until confirmed disease progression (up to 2 years)
2

Cohort 1 and 2: Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Time frame
From the date of first confirmed CR or PR until the first date of recurrent or progressive disease (up to 2 years)
3

Cohort 1 and 2: Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Time frame
From first dose of CTX-8371(Cycle 1 Day 1,Cycle = 2 weeks ) until disease progression or death, whichever occur first (up to 2 years)
4

Cohort 1 and 2: Objective Response Rate (ORR) (Percentage of Participants With Objective Response) as per Lugano (2014)

Time frame
Baseline until confirmed disease progression (up to 2 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Compass Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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