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First In Human Study of CX-2051 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-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 as a monotherapy and in combination with bevacizumab 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

Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1

Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload

Trial design

Design model

Sequential

Treatments tested in this trial

  • CX-2051

    Drug

    Investigational drug

  • Bevacizumab

    Drug

    IV infusion

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: CX-2051Experimental treatment 1 intervention
Group B: CX-2051 + bevacizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety and tolerability of CX-2051

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

Time to Treatment Failure (TTF)

TTF defined as the time from first dose of study intervention to the date of premature discontinuation for any reason, including tumor progression, severe toxicity, participant withdrawal, or death.

Time frame
60 months

Other outcomes

Sponsors and contacts

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

CytomX Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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