Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05431582
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZN-c3 — DRUG
    Given by PO 1 time a day with a glass (about 8 ounces) of water
  • Bevacizumab — DRUG
    Given by vein over about 30-60 minutes on Day 1 of each cycle
  • Pembrolizumab — DRUG
    Given by vein over 30-60 minutes on Day 1 of each cycle.

Study Details

Primary Objectives are to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 and ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors as well to evaluate antitumor activity of ZN-c3 and bevacizumab or ZN-c3 and bevacizumab plus pembrolizumab in metastatic CCNE1 amplified and TP53 mutant solid tumors.

Key Dates

First listed
Jun 24, 2022
Start date
Dec 14, 2022
Status verified
Feb 2023
Primary completion
Dec 14, 2022
Completion
Dec 14, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A
    ZN-c3 in combination with bevacizumab
  • Experimental: Regimen B
    ZN-c3 in combination with bevacizumab and pembrolizumab

Primary Outcome Measure

To establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of ZN-c3 . [ Time Frame: through study completion, an average of 1 year ]

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