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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

ConditionsLocally Advanced or Metastatic Solid TumorsNSCLCHNSCCMelanomaTNBCEsophageal CancerGastric CancerCervical CancerColorectal CancerUrothelial CarcinomaClear Cell RCCHCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenentech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Life expectancy of at least 12 weeks

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy

Disqualifiers

Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab

Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment

Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis

Positive test for human immunodeficiency virus (HIV) infection

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

450 Participants
are divided into 4 treatment groups
Group A: Phase Ia: Dose EscalationExperimental treatment 1 intervention
Group B: Phase Ia: ExpansionExperimental treatment 1 intervention
Group C: Phase Ib: Dose EscalationExperimental treatment 2 interventions
Group D: Phase Ib: ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)
2

Phase Ib: Number of Participants With 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)
3

Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to approximately 52 months
4

Phase Ib: Number of Participants With TEAEs

Time frame
Up to approximately 52 months

Secondary outcomes

1

Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug

Time frame
From Cycle 1 (each cycle is 21 days) Day 1, and at multiple timepoints up to each follow-up visits (up to approximately 52 months)
2

Phase Ia and Phase Ib: Objective Response Rate (ORR)

Time frame
From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
3

Phase Ia and Phase Ib: Duration of Response (DOR)

Time frame
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)
4

Phase Ia and Phase Ib: Progression-free Survival (PFS)

Time frame
From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 52 months)

Other outcomes

Sponsors and contacts

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

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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