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A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas

ConditionsBladder CancerSquamous Cell Carcinoma of the LungEsophageal Squamous Cell CarcinomaTongue Squamous Cell CarcinomaCutaneous Squamous Cell CancerPenile Squamous Cell CarcinomaAnal Squamous Cell CarcinomaVulvar Squamous Cell CarcinomaCervical Squamous Cell CarcinomaVaginal Squamous Cell CarcinomaUrethral Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEvolveImmune United, Inc

About this trial

The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.

The cancer must be measurable by CT scan or MRI.

Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.

Anticipated life expectancy of at least 3 months.

Disqualifiers

The participant is a candidate for treatment with a targeted agent known to provide a benefit.

Persistent significant toxicities from prior anticancer therapy.

Brain metastases unless previously treated and stable.

Prior severe or life-threatening immunologic reactions to previous therapies.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EVOLVE104

    Drug

    EVOLVE104 is provided as a solution for injection via IV infusion

  • EVOLVE104

    Drug

    Dose levels for Phase 1b will be determined based on the outcome of Phase 1a

Treatment groups

160 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: Phase 1a Cohort 1; dose level 1Experimental treatment 1 intervention
Group B: Phase 1a Cohort 2; dose level 2Experimental treatment 1 intervention
Group C: Phase 1a Cohort 3; dose level 3Experimental treatment 1 intervention
Group D: Phase 1a Cohort 4; dose level 4Experimental treatment 1 intervention
Group E: Phase 1a Cohort 5; dose level 5Experimental treatment 1 intervention
Group F: Phase 1a Cohort 6; dose level 6Experimental treatment 1 intervention
Group G: Phase 1a Cohort 7; dose level 7Experimental treatment 1 intervention
Group H: Phase 1a Cohort 8; dose level 8Experimental treatment 1 intervention
Group I: Phase 1a Cohort 9; dose level 9Experimental treatment 1 intervention
Group J: Phase 1a Cohort 10; dose level 10Experimental treatment 1 intervention
Group K: Phase 1b Cohort 1; dose level TBDExperimental treatment 1 intervention
Group L: Phase 1b Cohort 2; dose level TBDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

TEAEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability

Time frame
Baseline, through study completion, an average of 10 months.
2

Number of patients with Dose Limiting Toxicities (DLTs)

Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.

Time frame
Baseline, through study completion, an average of 10 months.
3

To determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) for EVOLVE104

Safety evaluations will occur consistently for each subject and across patients to assess MTD or RDE. Evaluations include analysis of TEAEs as well as ongoing assessments of laboratories, ECGs and physical examinations.

Time frame
Baseline, through study completion, an average of 10 months.
4

To determine the recommended phase 2 dose (RP2D) of EVOLVE104

Selection of the RP2D will be based on the aggregate safety, efficacy, PK, and PD observations for the entire study

Time frame
Safety evaluations will be done as described above. PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.

Secondary outcomes

1

Assess the efficacy of EVOLVE104

Efficacy will be evaluated through analysis of the overall response rate (ORR), including rates of complete response (CR), partial response (PR); and duration of response (DOR), and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Time frame
Baseline, through study completion, an average of 10 months.
2

Evaluate the Cmax of EVOLVE104

The maximum observed plasma concentration will be evaluated.

Time frame
PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.
3

Evaluate the Tmax of EVOLVE104

The duration of time taken to reach Cmax will be evaluated.

Time frame
PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.
4

Evaluate the Area Under the Curve (AUC) for EVOLVE104

AUC time curve from 0 to 24 hrs post dose and percent difference between intervals will be evaluated.

Time frame
PK and PD to be done each cycle (28 days) at pre-dose and post dose starting Day 1 at various time points, dependent upon treatment regimen assigned, through study completion, an average of 10 months.

Other outcomes

Sponsors and contacts

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

EvolveImmune United, Inc

Lead sponsor

Source ClinicalTrials.gov
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