85 Participants Needed

DS-9606a for Cancer

Recruiting at 9 trial locations
Cf
Overseen ByContact for Clinical Trial Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests DS-9606a, a new drug, in patients with advanced solid tumors to see if it is safe and effective. Researchers want to know if it can slow tumor growth and how the body handles the drug.

Will I have to stop taking my current medications?

The trial mentions an 'adequate treatment washout period' before starting the study treatment, which suggests you may need to stop certain medications. However, the specific medications or duration are not detailed, so it's best to discuss this with the trial team.

What data supports the effectiveness of the drug DS-9606a for cancer?

Research shows that targeting CLDN6, a protein found in many cancers but not in normal tissues, is promising for cancer treatment. Antibody-drug conjugates (ADCs) like DS-9606a, which target CLDN6, have been developed and show potential in treating cancers by delivering powerful drugs directly to cancer cells.12345

What safety data exists for DS-9606a or similar treatments targeting CLDN6 in cancer?

In a study of a similar treatment called ASP1650 targeting CLDN6, no serious safety issues were reported, and no dose-limiting toxicities were observed, suggesting it was generally safe at the tested doses.12456

What makes the drug DS-9606a unique for cancer treatment?

DS-9606a is unique because it targets CLDN6, a specific protein found in some cancer cells, and uses a PBD (pyrrolobenzodiazepine) ADC (antibody-drug conjugate) to deliver a potent anti-cancer agent directly to these cells, potentially reducing harm to healthy cells compared to traditional chemotherapy.7891011

Research Team

CD

Clinical Director

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

Adults with advanced solid tumors, including ovarian and germ cell cancers, who are in good physical condition (ECOG score of 0 or 1) can join. They must have a life expectancy over 3 months, proper heart function, and agree to contraception. Those with brain metastases treated successfully may qualify; however, individuals with recent serious heart issues or uncontrolled infections cannot participate.

Inclusion Criteria

You are expected to live for at least 3 more months.
I have ovarian cancer.
I am fully active or can carry out light work.
See 11 more

Exclusion Criteria

Your heart's electrical activity shows a QT interval that is too long based on multiple ECG readings.
I have had serious heart issues, including heart failure or irregular heartbeat needing treatment.
I have not had a heart attack or unstable chest pain in the last 6 months.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive an intravenous (IV) dose of DS-9606a starting at 0.016 mg/kg every 3 weeks to determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE)

Varies
Every 3 weeks

Dose Expansion

Participants with ovarian cancer receive an intravenous (IV) dose of DS-9606a at the recommended dose for expansion (RDE) every 3 weeks to further explore safety and tolerability and assess the overall response rate

Varies
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

  • DS-9606a
Trial OverviewThe trial is testing DS-9606a's safety for patients with various advanced solid tumors. It will involve participants providing tissue samples before and during treatment to assess the drug's effects on their cancer.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dose Expansion: DS-9606aExperimental Treatment1 Intervention
Participants with ovarian cancer who will receive an intravenous (IV) dose of DS9606a at the recommended dose for expansion (RDE) every 3 weeks.
Group II: Dose Escalation: DS-9606aExperimental Treatment1 Intervention
Participants who will receive an intravenous (IV) dose of DS9606a starting at 0.016 mg/kg every 3 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Daiichi Sankyo, Inc.

Lead Sponsor

Trials
390
Recruited
442,000+
Yuki Abe profile image

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Daiichi Sankyo

Lead Sponsor

Trials
443
Recruited
493,000+
Hiroyuki Okuzawa profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Findings from Research

CLDN6-23-ADC is a novel antibody-drug conjugate that selectively targets the CLDN6 protein, which is highly expressed in ovarian and endometrial cancers but not in normal adult tissues, making it a promising therapeutic option.
In preclinical studies, CLDN6-23-ADC demonstrated significant antitumor efficacy, leading to robust tumor regressions and improved survival in mouse models of CLDN6-positive cancers, and it is currently being evaluated in a phase I clinical trial.
Preclinical Efficacy of the Antibody-Drug Conjugate CLDN6-23-ADC for the Treatment of CLDN6-Positive Solid Tumors.McDermott, MSJ., O'Brien, NA., Hoffstrom, B., et al.[2023]
The newly developed m276-SL-PBD antibody-drug conjugate (ADC) targets CD276/B7-H3 and effectively eradicates large triple-negative breast cancer xenografts at doses 10- to 40-fold lower than previously tolerated doses, indicating a significant improvement in safety and efficacy.
This ADC demonstrates a cross-species reactivity and enhanced therapeutic index, suggesting that careful engineering and optimization of ADCs can lead to more effective cancer treatments with reduced side effects.
Engineering CD276/B7-H3-targeted antibody-drug conjugates with enhanced cancer-eradicating capability.Feng, Y., Lee, J., Yang, L., et al.[2023]
In a phase 1 study involving 60 patients with relapsed B-cell non-Hodgkin lymphoma, the anti-CD79B antibody-drug conjugate DCDS0780A showed a response rate of 47%, with 28% achieving complete responses, indicating its potential efficacy as a treatment option.
Despite the promising antitumor activity, the study noted significant ocular toxicities at higher doses, which limited dose intensity and suggested that the current TDC format may not expand the therapeutic index for targeting CD79B.
Anti-CD79B Antibody-Drug Conjugate DCDS0780A in Patients with B-Cell Non-Hodgkin Lymphoma: Phase 1 Dose-Escalation Study.Herrera, AF., Patel, MR., Burke, JM., et al.[2023]

References

Preclinical Efficacy of the Antibody-Drug Conjugate CLDN6-23-ADC for the Treatment of CLDN6-Positive Solid Tumors. [2023]
Engineering CD276/B7-H3-targeted antibody-drug conjugates with enhanced cancer-eradicating capability. [2023]
Anti-CD79B Antibody-Drug Conjugate DCDS0780A in Patients with B-Cell Non-Hodgkin Lymphoma: Phase 1 Dose-Escalation Study. [2023]
[Advances of Claudin6-targeting drugs in cancer therapy]. [2023]
The Role of Specific ATP-Binding Cassette Transporters in the Acquired Resistance to Pyrrolobenzodiazepine Dimer-Containing Antibody-Drug Conjugates. [2021]
A phase II study assessing the safety and efficacy of ASP1650 in male patients with relapsed refractory germ cell tumors. [2023]
[A case of recurrent lung cancer successfully treated with vinorelbine and cisplatin/carboplatin]. [2018]
Efficacy of a continuous venous infusion of fluorouracil and daily divided dose cisplatin as adjuvant therapy in resectable colorectal cancer: a prospective randomized trial. [2021]
Combination therapy of S-1 and CDDP for patients with colorectal cancer. [2018]
[Phase II studies of a single agent and a cis-platinum-based two-drug combination in patients with non-small cell lung cancer]. [2013]
11.United Statespubmed.ncbi.nlm.nih.gov
A multicenter phase I trial of PX-866, an oral irreversible phosphatidylinositol 3-kinase inhibitor, in patients with advanced solid tumors. [2021]