MedTrace Logo

Study of Upifitamab Rilsodotin in Combination With Carboplatin in Participants With High-grade Serous Ovarian Cancer

NCT04907968 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-10-10

No results posted yet for this study

Summary

Phase 1 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks in combination with Carboplatin in participants with high-grade serous ovarian cancer (HGSOC, including fallopian tube and primary peritoneal cancer). The trial consists of dose escalation (DES) and expansion (EXP) portion. In addition to safety assessments, the pharmacokinetics of the drug will be assessed along with ADC activity.

Conditions

  • Platinum-sensitive Ovarian Cancer (UPGRADE-A)

Interventions

DRUG

XMT-1536 (Upifitamab Rilsodotin)

Drug: XMT-1536 (Upifitamab Rilsodotin) XMT-1536 (Upifitamab Rilsodotin) will be administered on Day 1 of each 28-day cycle until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study Other Names: * XMT-1536 * UpRi Drug: Carboplatin Carboplatin will be administered on Day 1 on each of the first six 28 day cycles.

DRUG

Carboplatin

Drug: XMT-1536 (Upifitamab Rilsodotin) XMT-1536 (Upifitamab Rilsodotin) will be administered on Day 1 of each 28-day cycle until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study Other Names: * XMT-1536 * UpRi Drug: Carboplatin Carboplatin will be administered on Day 1 on each of the first six 28 day cycles.

Sponsors & Collaborators

  • IQVIA Biotech

    collaborator INDUSTRY

  • PSI CRO

    collaborator INDUSTRY

  • Mersana Therapeutics

    lead INDUSTRY

Principal Investigators

  • Brad Sumrow, MD · Mersana Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2023-10-03
Completion
2023-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04907968 on ClinicalTrials.gov