A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Conditions

• Cervical Cancer
• Clear Cell RCC
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• HCC
• HNSCC
• Locally Advanced or Metastatic Solid Tumors
• Melanoma
• NSCLC
• TNBC
• Urothelial Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enzelkitug — DRUG
  Enzelkitug will be administered as per the schedule specified in the respective arms.
• Atezolizumab — DRUG
  Atezolizumab will be administered as per the schedule specified in the respective arms.
• Pembrolizumab — DRUG
  Pembrolizumab will be administered as per the schedule specified in the respective arms.

Study Details

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

Key Dates

Start date

Oct 20, 2022

Status verified

Jun 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

450 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase Ia: Dose Escalation
  Participants in successive cohorts will receive escalating doses of enzelkitug, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
• Experimental: Phase Ia: Expansion
  Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ia dose escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
• Experimental: Phase Ib: Dose Escalation
  Participants in successive cohorts will receive escalating doses of enzelkitug, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
• Experimental: Phase Ib: Expansion
  Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ib dose escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Primary Outcome Measure

Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days) ]

Central Contacts

• Reference Study ID Number: GO43860 https://forpatients.roche.com/
  888-662-6728 (U.S. Only)
  [email protected]
• Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry

Locations (11)

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