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This is a Phase 1, multicenter, open-label, dose-escalation study of DMUC4064A administered by intravenous (IV) infusion every three weeks (q3w) to cancer participants. The study will employ a traditional 3 + 3 dose escalation design to determine the maximum tolerated dose (MTD) of DMUC4064A against platinum-resistant ovarian cancer. Once a q3w recommended Phase 2 dose (RP2D) is identified, two expansion cohorts (one in platinum-resistant ovarian cancer and another in unresectable pancreatic cancer) may be evaluated to further characterize the safety and activity in these populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-escalation Cohort | Experimental | DMUC4064A will be administered to participants at a starting dose of 1.0 milligram per kilogram (mg/kg) by IV infusion q3w and would be monitored for DLTs for 21 days after first infusion of Cycle 1 (cycle length=21 days). |
|
| Platinum-resistant Ovarian Cancer Dose-expansion Cohort | Experimental | Platinum-resistant Ovarian Cancer participants will be administered with the identified RP2D during the Dose-escalation of DMUC4064A q3w IV for up to until disease progression or death, whichever occurs first. |
|
| Unresectable Pancreatic Cancer Dose-expansion Cohort | Experimental | Unresectable pancreatic cancer participants will be administered with the identified RP2D during the dose-escalation of DMUC4064A q3w IV for up to until disease progression or death, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMUC4064A | Drug | Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | Day 1 up to Day 21 of Cycle 1 (Cycle length[CL]= 21 days) | |
| Maximum Tolerated Dose of DMUC4064A | Day 1 up to Day 21 of Cycle 1 (CL=21 days) | |
| Recommended Part II Dose of DMUC4064A | Baseline up to safety-follow up (approximately 3.5 years) | |
| Percentage of Participants with Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to safety-follow up (approximately 3.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Anti-DMUC4064A Antibodies | Pre-dose (0 hour[H];post infusion (infusion=90 minutes for C1; 30 minutes for C2 and beyond) on Day 1 of Cycle (C) 1-4; at study completion or early termination (approximately 3.5 years (CL=21 days) | |
| Pharmacokinetic (PK) Profile of DMUC4064A in Participants With Platinum-Resistant Ovarian Cancer or Unresectable Pancreatic Cancer |
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Inclusion Criteria:
For ovarian cancer dose expansion cohorts only:
Participants with Pancreatic Cancer:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists - Sarasota (North Catttlemen Rd) | Sarasota | Florida | 34232 | United States | ||
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| Days 1,2,4,8,11,15 of C1;Days 8,15 of C2-4; at study completion or early termination (approximately 3.5 years) |
| Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days) |
| Duration of Objective Response | At baseline and even numbered cycles and at study termination (approximately 3.5 years) (CL=21 days) |
| Progression-free Survival (PFS) as Assessed by RECIST v1.1 | Day 1 of C1 until disease progression or death within 30 days of the last study drug administration, whichever occurs first (approximately 3.5 years) (CL=21 days) |
| Massachusetts General Hospital. |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | United States |
| Hackensack Univ Med Ctr | Hackensack | New Jersey | 07601 | United States |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Sarah Cannon Research Inst. | Nashville | Tennessee | 37203 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
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