Platinum-resistant Ovarian CancerPhase 1NCT06515613
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
A Phase 1 study testing CTIM-76 in people with Platinum-resistant Ovarian Cancer and Testicular Cancer, run by Context Therapeutics Inc. at 15 sites in 2 countries.
Trial summary
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platinum-resistant Ovarian Cancer, Testicular Cancer, Endometrial Cancer
- What is being tested?
- CTIM-76
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 10 Jul 2024to 31 Dec 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
- Participants with measurable disease per RECIST 1.1.
- ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
- Participants with adequate organ function.
Who cannot join
- Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.
- Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study.
- Concurrent participation in another investigational clinical trial.
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States14 sites, 10 recruiting
- Withdrawn
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Rebecca Porter, MD, 877-338-7425, Rebecca_Porter@DFCI.HARVARD.EDU
- Withdrawn
Gabrail Cancer Center
Canton, Ohio, 44718
- Recruiting
SCRI at Mary Crowley
Dallas, Texas, 75230
Angela Hotchkiss, 214-658-1958, ahotchkiss@marycrowley.org
- Recruiting
SCRI at Denver Health
Denver, Colorado, 80218
Front Desk, 720-754-2610, CANN.DDUDenverGeneral@SarahCannon.com
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Duke Cancer Institute - Phase I and Immunotherapy Trials, 919-684-6342, Phase1andImmunotherapyreferrals@duke.edu
- Terminated
John Theurer Cancer Center
Hackensack, New Jersey, 07601
- Recruiting
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Maroof Zafar, 501-686-8274 ext. 24576, MKZafar@uams.edu
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO), 800-811-8480, CTIP@VUMC.ORG
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Roisin O'Cearbhaill, MD, ocearbhr@mskcc.org
- Recruiting
University of Nebraska Medical
Omaha, Nebraska, 68198
Marnee Strege, RN BSN, 402-559-8155
- Withdrawn
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Recruiting
Providence Cancer Institute of Oregon
Portland, Oregon, 97213
Christopher Darus, MD, 503-215-2075, CanRsrchStudies@Providence.org
- Recruiting
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Mary Dionne, 401-453-8181, MDionne@WIHRI.org
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
UCLH Referrals, uclh.referrals.clinicalresearchfacility@nhs.net
About this study
Official title: A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).
Read the detailed description
The phase 1a dose escalation portion of the trial will enroll participants with PRROC, testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision.
The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . This is to enable dose- and exposure-response analyses. The expansion doses/dosing schedules for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a.
The selection of the RP2D will be based on the totality of data from Phase 1b.
- Being tested
- CTIM-76
- Medical subject headings
- Testicular Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTIM-76Drug
Also called CTIM-76 Claudin 6 bispecific Antibody
CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| CTIM-76 | Experimental | Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts.
Phase 1b: Dose Expansion - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76 Receives: Drug: CTIM-76 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities (DLTs)
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
Measured: From date of first dose of CTIM-76 until 28 days following the first dose
Overall response rate (ORR)
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
Measured: From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start10 Jul 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-resistant 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will be evaluated in PRROC at a minimum of 2 dose levels and /or dosing schedules in the dose expansion phase of the trial (Phase 1b) to enable dose- and exposure-response analyses.
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Context Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Chagin, MD, Study chair, Context Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515613
- Sponsor's protocol ID
- CNTX-CTIM76-101
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06515613
- Acronym / sponsor ID
- CNTX-CTIM76-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Context Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jul 2024 (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 Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).
Detailed description
The phase 1a dose escalation portion of the trial will enroll participants with PRROC, testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision.
The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . This is to enable dose- and exposure-response analyses. The expansion doses/dosing schedules for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a.
The selection of the RP2D will be based on the totality of data from Phase 1b.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will be evaluated in PRROC at a minimum of 2 dose levels and /or dosing schedules in the dose expansion phase of the trial (Phase 1b) to enable dose- and exposure-response analyses.
| Arm | Type | Receives |
|---|---|---|
| CTIM-76 | Experimental | Drug: CTIM-76Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts. Phase 1b: Dose Expansion - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
- Participants with measurable disease per RECIST 1.1.
- ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
- Participants with adequate organ function.
Key exclusion criteria (3 listed)
- Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.
- Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study.
- Concurrent participation in another investigational clinical trial.
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 |
|---|---|---|
| CTIM-76Also: CTIM-76 Claudin 6 bispecific AntibodyCLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression. | Drug | CTIM-76 |
Primary outcome
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: From date of first dose of CTIM-76 until 28 days following the first dose
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
Overall response rate (ORR)
Time frame: From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Karen Chagin, MD study chair
Context Therapeutics Inc.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTIM-76 in people with Platinum-resistant Ovarian Cancer and Testicular Cancer, run by Context Therapeutics Inc. at 15 sites in 2 countries.
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 4 inclusion and 3 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, United Kingdom. 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 Context Clinical Development (267-225-7416, cntx-ctim76-101@contexttherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities (DLTs) (time frame: From date of first dose of CTIM-76 until 28 days following the first dose). The study lists 2 primary outcomes in all. 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 3 Sep 2026.