CUSP06 for Ovarian Cancer

Recruiting at 9 trial locations

Overseen By Priya Marreddy

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: OnCusp Therapeutics, Inc.

Must not be taking: Antiseizure, Corticosteroids

Disqualifiers: Brain metastases, Lung disease, Cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

263 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called CUSP06 for individuals with ovarian cancer that hasn't responded well to standard platinum-based therapies. The study aims to determine the treatment's safety and effectiveness, as well as how the body processes it. Participants should have previously received treatment for advanced solid tumors, including ovarian cancer, where standard treatments did not work or aren't available. This trial may suit those who have undergone such treatments and face limited options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that systemic antineoplastic therapy should not be taken within 5 half-lives or 4 weeks before the first dose of the study drug, whichever is shorter.

Is there any evidence suggesting that CUSP06 is likely to be safe for humans?

Research has shown that CUSP06 has a good safety record in early studies. These studies tested CUSP06 on animals like rats and monkeys, yielding promising results. The treatment was well-tolerated, with no serious side effects observed in the animals, indicating a positive sign for safety.

Now in the first phase of human testing, researchers are still learning about its effects on people. This phase focuses on assessing the treatment's safety and how the body processes it. While specific human data is not yet available, the animal tests suggest that CUSP06 might also be safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the CUSP06 treatment for ovarian cancer because it offers a fresh approach compared to traditional chemotherapy and targeted therapy options. Unlike conventional treatments that often target fast-dividing cells indiscriminately, CUSP06 is designed to specifically target and disrupt certain pathways critical to cancer cell survival, potentially reducing side effects and enhancing effectiveness. Additionally, CUSP06 may work synergistically with the body's immune system, offering a dual-action approach to fighting cancer cells. This innovative mechanism of action could lead to improved outcomes for patients with ovarian cancer who have limited options with current therapies.

What evidence suggests that CUSP06 might be an effective treatment for ovarian cancer?

Research has shown that CUSP06 yields promising results for treating ovarian cancer that no longer responds to standard chemotherapy. Early findings suggest that CUSP06, a treatment targeting the protein CDH6, can shrink tumors, particularly in cases with low levels of this protein. Due to its potential to aid in hard-to-treat ovarian cancer, the FDA has fast-tracked this treatment. Although more research is needed, these early results offer hope for those facing this challenging condition. Participants in this trial will join different cohorts to further explore and expand on these findings. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors, including ovarian cancer that's not responding to platinum-based treatments. Participants need a certain level of health (ECOG status 0 or 1), enough white blood cells, platelets, and hemoglobin without recent transfusions. They must provide tumor tissue samples and consent to biopsies if needed.

Inclusion Criteria

Willingness to undergo a pretreatment biopsy if medically feasible and safe

Written informed consent provided prior to any screening procedures

Willingness to provide archival tumor tissue collected within the previous 2 years, when available

Exclusion Criteria

I have a lung condition that needed steroid treatment in the last 6 months.

Concurrent participation in another investigational clinical trial

Pregnant or breast-feeding females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Finding - Phase 1a

Participants receive CUSP06 to evaluate safety, tolerability, and pharmacokinetics

36 months

Expansion as Monotherapy - Phase 1b

Further evaluation of CUSP06 efficacy and safety in a larger cohort

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CUSP06

Trial Overview CUSP06 is being tested in this phase 1 study for safety and effectiveness in treating resistant ovarian cancer and other solid tumors. The trial will assess how the body processes the drug (pharmacokinetics) as well as its impact on the disease.

How Is the Trial Designed?

Group I: Exploratory Cohort 1 Experimental Treatment 1 Intervention

Group II: Expansion Cohort 2 Experimental Treatment 1 Intervention

Group III: Expansion Cohort 1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

OnCusp Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

180+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3042

First-in-human (FIH) phase 1 study of CUSP06, a cadherin- ... Methods: CUSP06-1001 is a Phase 1a/1b, open-label, multi-center dose escalation and expansion study to evaluate safety, tolerability, ...

2. prnewswire.com prnewswire.com/news-releases/oncusp-therapeutics-announces-encouraging-initial-phase-1a-results-from-ongoing-first-in-human-study-evaluating-its-cdh6-directed-antibody-drug-conjugate-cusp06-in-platinum-refractoryresistant-ovarian-cancer-and-other-advanced--302470621.html

OnCusp Therapeutics Announces Encouraging Initial ... The primary objective of the study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in patients with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12388900/

CUSP06, a Novel CDH6-Targeted Antibody-Drug Conjugate ... The data indicate that CUSP06 could have strong antitumor efficacy in CDH6-low tumors. 3.3. Antitumor Activity of CUSP06 in Ovarian and Renal ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/oncusp-positive-cusp06/

ASCO25: OnCusp reports positive initial Phase Ia data ... OnCusp Therapeutics has reported initial Phase Ia data from its Phase I trial of the CDH6-directed antibody-drug conjugate (ADC), CUSP06.

5. targetedonc.com targetedonc.com/view/fda-fast-tracks-cusp06-in-platinum-resistant-ovarian-cancer

FDA Fast Tracks CUSP06 in Platinum-Resistant Ovarian ... The FDA has granted CUSP06, a CDH6-directed ADC, fast track designation for the treatment of patients with platinum-resistant ovarian cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06234423

NCT06234423 | A Study of CUSP06 in Patients With ... This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40871070/

CUSP06, a Novel CDH6-Targeted Antibody-Drug ... CUSP06 demonstrated a favorable safety profile in GLP-compliant toxicology studies in Sprague Dawley rats and cynomolgus monkeys. Conclusions: ...

8. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-cusp06-for-platinum-resistant-ovarian-cancer

FDA Grants Fast Track Designation to CUSP06 for ... The phase 1a/1b trial evaluates CUSP06's safety, tolerability, pharmacokinetics, and efficacy in CDH6-positive tumors, including ovarian cancer ...