Ovarian Cancer Clinical Trial
Official title:
A Phase 1, First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 (CLDN6)
This study will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | February 19, 2026 |
Est. primary completion date | February 19, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years old at the time of written informed consent - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 - Availability of archived tumor tissue samples (mandatory); patients with germ cell tumors without archived tumor samples may be allowed with approval - Has a left ventricular ejection fraction (LVEF) =50% as determined by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before the start of study treatment - Adequate bone marrow and organ function within 7 days before the start of study treatment - Life expectancy =3 months - Adequate treatment washout period prior to start of study treatment - Male patients with female partners of childbearing potential and female patients of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug. Males must agree not to freeze or donate sperm throughout the study period for at least 4 months after final administration of study drug. Females must agree not to donate or retrieve ova for own use throughout the study period and for at least 7 months after final study drug administration. Dose Escalation Participants Only: - Histologically- or cytologically-documented locally advanced or metastatic cancers, including but not limited to: ovarian cancer (including fallopian tube and primary peritoneal carcinoma), germ cell tumors, uterine and endometrial cancers, pancreatic adenocarcinoma, non-squamous NSCLC, or gastric cancer - Disease progression with standard of care therapies for metastatic disease known to confer benefit, or are intolerant to or refuse standard treatment. Dose Expansion Participants Only: - Consent to provide pre-treatment (mandatory) and on-treatment tissue biopsy sample (mandatory if not clinically contraindicated) - Histologically or cytologically-documented locally advanced or metastatic cancers including: - Cohort B-1: Ovarian cancer - Cohort B-2: Refractory germ cell tumors Exclusion Criteria: - Has history or current presence of central nervous system metastases, except for participants who have completed radiotherapy or surgery =4 weeks before the start of treatment, and fulfill all criteria (no evidence of disease progression in the CNS and no requirement for chronic corticosteroids) within 2 weeks before the start of treatment - Other invasive malignancy within 2 years; prior or concurrent non-invasive malignancies and/or patients with localized malignancies that were treated with curative intent who remain disease-free and are considered low likelihood for recurrence may be enrolled - History of myocardial infarction or unstable angina within 6 months before study treatment - Has a history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment - Has a corrected QT interval by Fridericia's formula (QTcF), of >470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read - Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. - Has an uncontrolled infection requiring ongoing or long-term therapy - Has a known active hepatitis or uncontrolled hepatitis B or C infection |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sarah Cannon Research Institute UK | London | |
United Kingdom | The Royal Marsden NHS Trust | London | |
United States | SCRI at HealthONE | Denver | Colorado |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | SCRI Oncology Partners | Nashville | Tennessee |
United States | Florida Cancer Specialists & Research Institute, LLC | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo, Inc. |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Dose-Limiting Toxicities (DLT) in Participants Receiving DS-9606a | Cycle 1 Day 1 through Day 21 of Cycle 2 (each cycle is 21 days) | ||
Primary | Number of Participants with Treatment-emergent Adverse Events (TEAEs) in Participants Receiving DS-9606a | Cycle 1 Day 1 to 30 days after last dose, up to 36 months (each cycle is 21 days) | ||
Primary | Overall Response Rate of DS-9606a as Assessed by the Investigator in Participants Receiving DS-9606a (Dose Expansion) | Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) | ||
Secondary | Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) | Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) | ||
Secondary | Pharmacokinetic Parameter Maximum Concentration (Cmax) | Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) | ||
Secondary | Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) | Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) | ||
Secondary | Pharmacokinetic Parameter Trough Concentration (Ctrough) | Cycles 1-3, Day 1:pre-dose, end of flush, 4 hours (hr) and 8 hrs post-dose (Cycles 1 and 3 only); Cycle 1 and 3,Day 2; Cycle 1 and 3,Days 4,8, and 15; Cycle 2,Days 8 and 15; Cycle 4,Day 1 and pre-dose every cycle, up to 36 months (each cycle is 21 days) | ||
Secondary | Duration of Response (DoR) as Assessed by the Investigator in Participants Receiving DS-9606a | Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) | ||
Secondary | Disease Control Rate (DCR) as Assessed by the Investigator in Participants Receiving DS-9606a | Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) | ||
Secondary | Time to Response (TTR) as Assessed by the Investigator in Participants Receiving DS-9606a | Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) | ||
Secondary | Progression-free Survival (PFS) as Assessed by the Investigator in Participants Receiving DS-9606a | Cycle 1 Day 1 and then every 6 weeks for 24 weeks, and then every 12 weeks, up to 36 months (each cycle is 21 days) | ||
Secondary | Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Percentage of Participants Who Have Treatment-emergent ADA | Cycle 1 Days 1 and 15, Cycles 2 and 3 Day 1, Cycle 4 Day 1 and all cycles thereafter on Day 1, up to 36 months (each cycle is 21 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |