CTIM-76 for Ovarian Cancer

Recruiting at 9 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

Trial Summary

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.

What data supports the effectiveness of the drug CTIM-76 for ovarian cancer?

The research highlights that standard chemotherapy for advanced ovarian cancer, which includes drugs like carboplatin and paclitaxel, is effective in early stages with a 70-80% survival rate, but less so in advanced stages. Additionally, new treatments like PARP inhibitors have shown promise in improving outcomes for patients with specific genetic mutations, suggesting that innovative therapies can enhance treatment effectiveness. ^{1 2 3 4 5}

What is the purpose of this trial?

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 bispecific antibody targeting CLDN6, in subjects with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).

Research Team

Karen Smith, MD, PhD, MBA, LLM

Principal Investigator

Context Therapeutics Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

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

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Exploring the Clinical Impact of Predictive Biomarkers in Serous Ovarian Carcinomas. [2021]

4. Greece pubmed.ncbi.nlm.nih.gov

Multimodal Treatment of Primary Advanced Ovarian Cancer. [2021]

5. Thailand 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. [2023]