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A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

NCT03409458 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-18

No results posted yet for this study

Summary

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors.

The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.

Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

PT-112

The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort. For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15.

BIOLOGICAL

avelumab

Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • EMD Serono

    collaborator INDUSTRY

  • Promontory Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel D Karp, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2022-06-01
Completion
2022-08-31
FDA Drug
Yes

Countries

  • United States
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409458 on ClinicalTrials.gov