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A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVividion Therapeutics, Inc.

About this trial

A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed metastatic or unresectable solid tumor.

Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator.

Have progressed on or after all prior standard-of-care therapies for metastatic disease.

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

Disqualifiers

KEAP1 nonsense mutation (any position)

KEAP1 frameshift mutation (any position)

Any unresolved toxicity Grade ≥2 per CTCAE version 5.0 from previous anticancer treatment.

Current or prior treatment with anti-epileptic medications for the treatment or prophylaxis of seizures.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VVD-130037

    Drug

    Oral tablets

  • Docetaxel

    Drug

    IV infusion

  • Paclitaxel

    Drug

    IV infusion

  • Pembrolizumab

    Drug

    IV infusion

Treatment groups

290 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part 1 (Dose Escalation): VVD-130037 Single AgentExperimental treatment 1 intervention
Group B: Part 1 (Dose Escalation): VVD-130037 and Docetaxel Combination TherapyExperimental treatment 2 interventions
Group C: Part 1 (Dose Escalation): VVD-130037 and Paclitaxel Combination TherapyExperimental treatment 2 interventions
Group D: Part 2 (Dose Expansion): VVD-130037 Single AgentExperimental treatment 1 intervention
Group E: Part 2 (Dose Expansion): VVD-130037 and Docetaxel Combination TherapyExperimental treatment 2 interventions
Group F: Part 2 (Dose Expansion): VVD-130037 and Paclitaxel Combination TherapyExperimental treatment 2 interventions
Group G: Experimental: Part 2 (Dose Expansion): VVD-130037 and Pembrolizumab Combination TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period

Incidence and severity of DLTs will be assessed per DLT criteria set forth in the protocol based on adverse events (AEs) evaluated per National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
Part 1: Single Agent and Docetaxel/Pembrolizumab Combination Therapy: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days] and Part 1: Paclitaxel Combination Therapy: From Day 1 to Day 28 of Cycle 1 [cycle length=28 days]
2

Part 2 (Dose Expansion): Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory Abnormalities

Time frame
Up to approximately 4 years

Secondary outcomes

1

Part 1 (Dose Escalation): Number of Participants With AEs, SAEs, and Clinical Laboratory Abnormalities

Time frame
Up to approximately 4 years
2

Part 2 (Dose Expansion): Recommended Phase 2 Dose (RP2D) of VVD-130037 as a Single Agent and in Combination with Docetaxel, Paclitaxel, or Pembrolizumab

The RP2D will be based on safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of VVD-130037 as single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab during Part 2.

Time frame
Up to approximately 4 years
3

Part 2 (Dose Expansion): Overall Response Rate (ORR)

ORR is defined as the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment.

Time frame
Up to approximately 4 years
4

Part 2 (Dose Expansion): Duration of Response (DOR)

DOR is defined as the time from initial response of CR or PR to progressive disease or death, whichever comes first per RECIST version 1.1 by investigator assessment.

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

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

Vividion Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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