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First In Human Study of CX-801 in Advanced Solid Tumors

ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytomX Therapeutics

About this trial

The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Measurable disease per RECIST v1.1

Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue

Disqualifiers

Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated

Known active central nervous system (CNS) involvement by malignancy

Prior PD-1/ PD-(L)1 inhibitor treatment discontinued due to grade 3 or higher immune related adverse event

Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment

Trial design

Design model

Sequential

Treatments tested in this trial

  • CX-801

    Drug

    Investigational drug

  • pembrolizumab

    Drug

    Standard of Care Therapy

Treatment groups

121 Participants
are divided into 2 treatment groups
Group A: CX-801Experimental treatment 1 intervention
Group B: CX-801 + pembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and tolerability of CX-801 as monotherapy and combination therapy

The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level

Time frame
44 months
2

Determine the recommended Phase 2 dose (RP2D)

The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level

Time frame
44 months

Secondary outcomes

1

Objective response rate (ORR)

ORR defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator assessment.

Time frame
60 months
2

Duration of response (DOR)

DOR defined as the time from the first documentation of confirmed CR or PR (based on RECIST v1.1) to the first documentation of disease progression or death due to any cause on study, whichever occurs first.

Time frame
60 months
3

Progression-free survival (PFS)

PFS defined as the time from the first dose of study intervention to the date of first documentation of objective tumor progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.

Time frame
60 months
4

Disease control rate (DCR)

DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as per RECIST v1.1 by Investigator assessment.

Time frame
60 months

Other outcomes

Sponsors and contacts

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

CytomX Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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