A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

Vividion Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors; Advanced Hematologic Tumors

Treatments: Drug: VVD-130850; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06188208

2023-508386-32-00 (Other Identifier)

VVD-130850-01

Details and patient eligibility

About

A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).

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

3. Adequate organ and bone marrow function as defined in the protocol.

4. For Combination Therapy Expansion:

   • Serine/threonine kinase 11/ liver kinase B1 (STK11/LKB1) mutated non-small cell lung cancer (NSCLC) as assessed by historical (local) test.
   • Must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (CPI). These therapies could have been given in the same line of therapy or different lines of therapy.

5. Measurable disease by RECIST version 1.1 as assessed by the Investigator.

Key Exclusion Criteria:

1. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.

2. Prior allogeneic transplantation.

3. History of cardiac diseases as defined in detail in the protocol.

4. Clinically significant infection or any eye infection.

5. Active central nervous system (CNS) malignancies (previously treated CNS malignancies are not exclusionary).

6. Combination Therapy Expansion:

   • Known hypersensitivity or contraindication to pembrolizumab or any of its components.
   • Any prior toxicity (Grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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280 participants in 4 patient groups

Dose Escalation: VVD-130850 Single Agent

Experimental group

Description:

Participants will receive ascending doses of VVD-130850, orally, once daily in 21-day treatment cycles during the dose escalation phase.

Treatment:

Drug: VVD-130850

Dose Escalation: VVD-130850 + Pembrolizumab Combination Therapy

Experimental group

Description:

Participants will receive ascending doses of VVD-130850, orally, once daily, along with pembrolizumab intravenous (IV) infusion, every 3 weeks (Q3W) in 21-day treatment cycles during the dose escalation phase.

Treatment:

Drug: Pembrolizumab

Drug: VVD-130850

Dose Expansion: VVD-130850 Single Agent

Experimental group

Description:

Participants will receive VVD-130850 at recommended dose for expansion (RDE), orally, once daily in 21-day treatment cycles during the dose expansion phase.

Treatment:

Drug: VVD-130850

Dose Expansion: VVD-130850 + Pembrolizumab Combination Therapy

Experimental group

Description:

Participants will receive VVD-130850 at RDE orally, once daily along with pembrolizumab IV infusion, Q3W in 21-day treatment cycles during the dose expansion phase.

Treatment:

Drug: Pembrolizumab

Drug: VVD-130850