CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT05942300 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: HCC 21-249CA272218
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.

Conditions

Recurrent Ovarian Cancer

Keywords

platinum sensitive; stromal tumor microenvironment (TME); PARP inhibitor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of CPI-0209

  MTD will be determined via Dose-limiting toxicity (DLT)s defined as any grade 3-4 non-hematological or grade 4 hematological toxicity at least possibly related to the treatment, occurring during the first two cycles of treatment and per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 5.

  Up to 24 months

Secondary Outcomes (3)

• Adverse Events by Grade per CTCAE v5.0

  Up to 5.5 years

• Overall Response Rate (ORR)

  5.5 years

• Progression-free Survival (PFS)

  Up to 5.5 years

Study Arms (2)

CPI-0209 (100 mg) + carboplatin

EXPERIMENTAL

CPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Drug: CPI-0209; Drug: carboplatin

CPI-0209 (150 mg) + carboplatin

EXPERIMENTAL

CPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards

Drug: CPI-0209; Drug: carboplatin

Interventions

CPI-0209 DRUG

A second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time.

Also known as: Tulmimetostat

CPI-0209 (100 mg) + carboplatin; CPI-0209 (150 mg) + carboplatin

carboplatin DRUG

Carboplatin is a chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.

CPI-0209 (100 mg) + carboplatin; CPI-0209 (150 mg) + carboplatin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease \> 6 months after completing last platinum- based chemotherapy) that are eligible to receive platinum-based chemotherapy).
• Documented disease recurrence/progression based on GCIG-RECIST
• Must have had at least 1 prior line of platinum-based therapy, prior bevacizumab or PARPi use are allowed. Women with germline BRCA mutations should be considered for PARPi maintenance as standard of care treatment prior to consideration of clinical trial enrollment
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with life expectancy of ≥ 3months
• Adequate organ function
• Serum creatinine ≤1.5mg/dL or 24-hour clearance ≥50mL/min
• AST/ALT \<2.5x ULN (or \<5x ULN if liver metastasis are present)
• Total bilirubin ≤ ULN or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome
• Hemoglobin ≥9 gm/dl, Platelets ≥100,000/μl ANC ≥1500/μl
• INR ≤1.5
• Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
• Must be able to swallow CPI-0209 tablet/oral suspension
• Able to provide informed consent and comply with all study protocol
• Treated CNS metastasis allowed if treatment is completed ≥8 weeks prior to enrollment. Patients must be asymptomatic off systemic corticosteroids for at least 4 weeks after completion of radiation therapy. CNS disease must be stable or regressed on repeat imaging performed at least 4 weeks after completion of therapy.
• Women of child-bearing potential (those who have had a menstrual cycle within the last year and have not had a tubal ligation or surgical removal of both ovaries and/or hysterectomy) must agree to abstain from vaginal intercourse or use and continue highly effective methods of contraception for at least 183 days after discontinuation of study treatment.

You may not qualify if:

• Borderline or low malignant potential histology
• Platinum-resistant disease (as defined as progressive disease (PD) within 6 months of completion of chemotherapy with a platinum agent).
• Known hypersensitivity to any of the excipients of CPI-0209.
• Gastrointestinal (GI) dysfunction or disease that may significantly alter the absorption of the study drugs
• Concurrent malignancy or malignancy within 3 years prior to starting study drug with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer or per physician discretion that the previous cancer was adequately treated with curative intent and unlikely to recur (the study PI must concur with this determination).
• History of HIV infection
• Has an active infection requiring systemic treatment
• Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks and contraindicate patient's participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, significant cardiac/pulmonary disease etc.)
• Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
• Use of herbal supplements unless discontinued ≥7 days prior to initiation of study drug
• Consumption of foods which are strong inducers or inhibitors of CYP3A4/5 has to be discontinued 7 days prior to initiation of study drug. Patients that are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from the diet and all foods that contain those fruits from time of enrollment to through the duration of study participation will be excluded.
• Pregnant or breast feeding
• Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
• Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥25% of the bone marrow (Ellis, 1961) was irradiated.
• Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).

Sponsors & Collaborators

• Lan Coffman: lead
• Novartis Pharmaceuticals: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Magee-Womens Research Institute / UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Lan Coffman, MD, PhD

  UPMC Magee Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Mitch, RN

CONTACT

412-623-6793; adamkka2@upmc.edu

Joshua Plassmeyer, MS

CONTACT

412-648-6417; plassmeyerjm@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hematology/Oncology. Assistant Professor of Medicine.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)