CTIM-76 for Ovarian Cancer

Recruiting at 8 trial locations

Overseen By MaryBeth LeRose

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Context Therapeutics Inc.

Disqualifiers: CNS metastases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CTIM-76, designed for individuals with a specific type of ovarian cancer that doesn't respond well to standard treatments. The study aims to determine the safety and effectiveness of this treatment. It also includes participants with certain advanced cancers, such as testicular or endometrial, that express a protein called CLDN6. Those who have these cancers and can track their disease's progress might be suitable candidates. Participants should not have cancer that has spread to the brain or an uncontrolled infection. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for more details.

Is there any evidence suggesting that CTIM-76 is likely to be safe for humans?

Research shows that CTIM-76 is currently being tested for safety in humans. Detailed safety information is not yet available, as the testing process is still in its early stages. This trial is a Phase 1 study, focusing on assessing the treatment's safety.

Early trials like this one aim to determine the correct dose and identify any potential side effects. Safety remains the primary concern, so participants receive close monitoring. Notably, CTIM-76 has shown promising results in lab studies, particularly in shrinking tumors in ovarian cancer models. While this does not guarantee safety, it is an encouraging sign.

Participants in the trial will be closely monitored for any side effects. They will be informed about any risks and monitored to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which often include surgery and chemotherapy, CTIM-76 is unique because it targets cancer cells at a molecular level. Researchers are excited about CTIM-76 because it offers a novel mechanism of action that may reduce toxicity and enhance effectiveness by directly attacking cancer cells while potentially sparing healthy cells. This targeted approach could lead to fewer side effects and improved outcomes for patients compared to traditional treatments.

What evidence suggests that CTIM-76 might be an effective treatment for ovarian cancer?

Research has shown that CTIM-76, the investigational treatment in this trial, may help treat ovarian cancer. In animal studies, CTIM-76 stopped tumors from growing and even made some tumors disappear completely. This treatment is a special type of antibody that can attach to two different targets. It focuses on CLDN6, a protein found in some cancer cells, which helps the immune system find and attack the cancer. These early results suggest that CTIM-76 could be effective in fighting ovarian cancer, especially when traditional treatments have not worked. ^{2 3 6 7 8}

Who Is on the Research Team?

Karen Chagin, MD

Principal Investigator

Context Therapeutics Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with recurring ovarian cancer or other advanced solid tumors that are resistant to platinum-based treatments. Participants must have a tumor that tests positive for CLDN6, which the study drug targets.

Inclusion Criteria

My cancer is CLDN6 positive and resistant to platinum-based treatments.

My organs are functioning well.

Subject with measurable disease per RECIST 1.1

Exclusion Criteria

Concurrent participation in another investigational clinical trial

I have previously been treated with CLDN-6 targeted therapy.

My cancer has spread to my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1a: Participants receive CTIM-76 in escalating doses to assess safety and tolerability

28 days per cycle

Weekly visits for dosing

Dose Expansion

Phase 1b: Participants receive CTIM-76 at determined doses to evaluate response

28 days per cycle

Weekly visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• CTIM-76

Trial Overview The trial is testing CTIM-76, a new type of antibody designed to target and engage T cells against tumors. It's in early stages (Phase 1) where researchers are figuring out the right dose and checking how well it works on different cancers like ovarian, testicular, and endometrial.

How Is the Trial Designed?

Group I: CTIM-76 Experimental Treatment 1 Intervention

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 - 30 subjects will be evaluated using 2 different doses of CTIM-76

Who Is Running the Clinical Trial?

Context Therapeutics Inc.

Lead Sponsor

Trials

7

Recruited

260+

Published Research Related to This Trial

Optimal surgical debulking to achieve no residual disease (R0) significantly improves survival rates in patients with epithelial ovarian cancer, which is crucial given its high mortality rate.

The SOLO-1 trial demonstrated that olaparib, a maintenance therapy, significantly reduces the risk of disease progression by 70% in patients with advanced ovarian cancer who have BRCA mutations, highlighting its efficacy in targeted treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Treatment of Primary Advanced Ovarian Cancer. Friedrich, M., Friedrich, D., Kraft, C., et al.[2021]

Standard chemotherapy with paclitaxel and carboplatin is highly effective for early-stage epithelial ovarian cancer, achieving overall survival rates of 70-80%, but advanced stages show a concerning recurrence rate exceeding 80% and a 5-year overall survival of only 55%.

To improve long-term survival rates, new strategies are being explored, including the use of anti-angiogenic agents and PARP inhibitors, particularly for patients with BRCAness, which may offer more effective and personalized treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Maintenance therapy in patients with advanced epithelial ovarian cancer-impact of anti-angiogenic molecular targeted agents in progress]. Takeuchi, S., Sugiyama, T.[2019]

Epithelial ovarian cancer (EOC) has a high initial response rate to platinum-based treatments (70-80%), but long-term survival remains low due to chemoresistance and the disease's heterogeneity, which includes multiple histological subtypes.

Recent advancements in biomarker research, such as identifying BRCA and KRAS mutations, have led to the development of targeted therapies like PARP inhibitors and immunotherapy, which may improve treatment outcomes for patients with EOC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Clinical Impact of Predictive Biomarkers in Serous Ovarian Carcinomas. Le Page, C., Chung, J., Rahimi, K., et al.[2021]

In a study of 40 women with recurrent platinum-resistant and refractory epithelial ovarian cancer, the median survival times were 19 months for platinum-resistant patients and 21 months for platinum-refractory patients, indicating limited improvement in survival despite new treatment options.

Patients with clear cell carcinoma had a significantly lower median overall survival (14.4 months) compared to those with serous carcinoma (22.9 months) and other histologies (32.2 months), suggesting that this subtype may require more targeted treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Prognostic Factors of Patients with Platinum- Resistant or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer and Peritoneal Cancer. Hamontri, S., Tantitamit, T.[2023]

In a study involving 4,312 women with advanced-stage epithelial ovarian carcinoma, adding a third cytotoxic agent (gemcitabine, liposomal doxorubicin, or topotecan) to standard carboplatin and paclitaxel did not improve overall survival (OS) or progression-free survival (PFS).

The trial demonstrated that despite the addition of these agents, there were no significant benefits in survival outcomes, highlighting the need for new treatment strategies beyond current chemotherapy options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup. Bookman, MA., Brady, MF., McGuire, WP., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06515613?cond=%22Testicular%20Cancer%22&intr=%22Immunoglobulins%22&viewType=Table&rank=2

NCT06515613 | A Phase 1 Study of CTIM-76 in Patients ... 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 humanized T cell engaging ...

2. ir.contexttherapeutics.com ir.contexttherapeutics.com/news-releases/news-release-details/context-therapeutics-announces-ctim-76-trial-progress-poster

Context Therapeutics Announces CTIM-76 Trial in Progress ... It is presenting a Trial in Progress poster for the Phase 1 clinical trial evaluating CTIM-76 in ovarian, endometrial, and testicular cancers.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS2685

A phase 1, first-in-human study of CTIM-76, a claudin-6 ... CTIM-76 effectively inhibited tumor growth, inducing complete responses in ovarian cancer xenograft models. The first in human study of CTIM-76 ...

4. trialx.com trialx.com/clinical-trials/listings/296174/a-phase-1-study-of-ctim-76-in-patients-with-recurring-ovarian-cancer-and-other-advanced-solid-tumors/

A Phase 1 Study of CTIM-76 in Patients With Recurring ... 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 humanized ...

5. withpower.com withpower.com/trial/phase-1-platinum-resistant-ovarian-cancer-proc-6-2024-8fae9

CTIM-76 for Ovarian Cancer Standard chemotherapy with paclitaxel and carboplatin is highly effective for early-stage epithelial ovarian cancer, achieving overall survival rates of 70-80%, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06515613

NCT06515613 | A Phase 1 Study of CTIM-76 in Patients ... 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 humanized T cell engaging ...

7. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/context-therapeutics-ctim-76-dosed-in-first-patient-of-phase-1-trial/

Context Therapeutics CTIM-76 Dosed in First Patient of ... The trial is designed to evaluate the safety and efficacy of CTIM-76, with initial data expected in the first half of 2026. This trial marks a.

8. firstwordpharma.com firstwordpharma.com/story/6516562

Context Therapeutics Reports Third Quarter 2025 ... Ongoing Phase 1 trial of CTIM-76 (CLDN6 x CD3) demonstrates encouraging antitumor activity and safety. Ongoing Phase 1 trial of CT-95 (MSLN ...