Recurrent Ovarian CancerPhase 1NCT05942300
CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
A Phase 1 study testing CPI-0209 and carboplatin in people with Recurrent Ovarian Cancer, run by Lan Coffman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- CPI-0209 and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 30 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Who cannot join
- 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
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- 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).
- Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 5 Grade ≤1 (Exception to this criterion: patients with any grade of alopecia, controlled endocrine toxicities and/or neuropathy ≤ grade 2 are allowed to enter the study).
- Grade 3 baseline neuropathy
- Patient with a Child-Pugh score B or C.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Magee-Womens Research Institute / UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Kelsey Mitch, RN, 412-623-6793, adamikka@upmc.edu
Lan Coffman, MD
About this study
Official title: Phase I Trial of CPI-0209 in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
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.
Read the detailed description
Clinically, there is a critical need for improved therapies in ovarian cancer. There has been recent success with maintenance therapy in ovarian cancer with both PARP inhibitors and bevacizumab approved in the up-front maintenance setting and in the recurrent, platinum sensitive maintenance setting. However, it is unclear what treatment should be used post-PARPi or bevacizumab maintenance. Additionally, the benefit derived from bevacizumab maintenance therapy is modest with generally a few month improvement in progression free survival. Further, there is emerging evidence that after progression on a PARPi, there is decreased response to platinum-based therapy. This provides a critical unmet need to enhance platinum response, particularly after previous maintenance therapy. This also provides a large group of patients who could potentially benefit from EZH2 targeting agents to block stromal-mediated chemotherapy resistance and metastasis.
This study aims to investigate whether CPI-0209 will enhance ovarian cancer sensitivity to platinum-based chemotherapy and prolong the disease free interval after completion of chemotherapy by blocking stromal mediated chemotherapy resistance, metastasis promotion and ovarian cancer growth.
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- CPI-0209, carboplatin
- Keywords
- platinum sensitive, stromal tumor microenvironment (TME), PARP inhibitor
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-0209Drug
Also called Tulmimetostat
A second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time.
carboplatinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CPI-0209 (100 mg) + carboplatin | Experimental | CPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards Receives: Drug: CPI-0209; Drug: carboplatin |
| CPI-0209 (150 mg) + carboplatin | Experimental | CPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards Receives: Drug: CPI-0209; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (3)
Adverse Events by Grade per CTCAE v5.0
Number of patients that experienced grade 3 or greater Adverse events per the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 5, determined to be at least possibly, probably or definitely related to treatment.
Measured: Up to 5.5 years
Overall Response Rate (ORR)
Proportion of patients with Complete Response (CR) or Partial Response (PR) per RECIST v 1.1. Per RECIST v1.1: CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. PR is defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: 5.5 years
Progression-free Survival (PFS)
The length of time during and after treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Measured: Up to 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start30 Jan 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lan Coffman
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Lan Coffman, University of Pittsburgh
- Investigators
- Lan Coffman, MD, PhD, Principal investigator, UPMC Magee Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942300
- Sponsor's protocol ID
- HCC 21-249
- Other IDs
- CA272218
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of CPI-0209 in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05942300
- Acronym / sponsor ID
- HCC 21-249
- Conditions
- Recurrent Ovarian Cancer
- Keywords
- platinum sensitive, stromal tumor microenvironment (TME), PARP inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lan CoffmanUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals, National Cancer Institute (NCI)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Clinically, there is a critical need for improved therapies in ovarian cancer. There has been recent success with maintenance therapy in ovarian cancer with both PARP inhibitors and bevacizumab approved in the up-front maintenance setting and in the recurrent, platinum sensitive maintenance setting. However, it is unclear what treatment should be used post-PARPi or bevacizumab maintenance. Additionally, the benefit derived from bevacizumab maintenance therapy is modest with generally a few month improvement in progression free survival. Further, there is emerging evidence that after progression on a PARPi, there is decreased response to platinum-based therapy. This provides a critical unmet need to enhance platinum response, particularly after previous maintenance therapy. This also provides a large group of patients who could potentially benefit from EZH2 targeting agents to block stromal-mediated chemotherapy resistance and metastasis.
This study aims to investigate whether CPI-0209 will enhance ovarian cancer sensitivity to platinum-based chemotherapy and prolong the disease free interval after completion of chemotherapy by blocking stromal mediated chemotherapy resistance, metastasis promotion and ovarian cancer growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPI-0209 (100 mg) + carboplatin | Experimental | Drug: CPI-0209, Drug: carboplatinCPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards |
| CPI-0209 (150 mg) + carboplatin | Experimental | Drug: CPI-0209, Drug: carboplatinCPI-0209: 100 mg (oral dosing) carboplatin administered intravenously as per institutional standards |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-0209Also: TulmimetostatA second-generation EZH2 inhibitor that has been designed to achieve comprehensive anti-cancer target coverage through extended on-target residence time. | Drug | CPI-0209 (100 mg) + carboplatin, CPI-0209 (150 mg) + carboplatin |
| carboplatinCarboplatin 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. | Drug | CPI-0209 (100 mg) + carboplatin, CPI-0209 (150 mg) + carboplatin |
Primary outcome
Maximum tolerated dose (MTD) of CPI-0209
Time frame: Up to 24 months
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.
3 secondary outcomes
Adverse Events by Grade per CTCAE v5.0
Time frame: Up to 5.5 years
Overall Response Rate (ORR)
Time frame: 5.5 years
Progression-free Survival (PFS)
Time frame: Up to 5.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lan Coffman, MD, PhD principal investigator
UPMC Magee Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-0209 and carboplatin in people with Recurrent Ovarian Cancer, run by Lan Coffman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Mitch, RN (412-623-6793, adamkka2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of CPI-0209 (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.