Advanced Ovarian Carcinoma Clinical Trial
Official title:
A Phase 1b Study of ONT 10 and Varlilumab in Patients With Advanced Ovarian Cancer or Breast Cancer
This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with varlilumab. Two different doses of varlilumab will be studied in combination with the single agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may also be studied at the recommendation of the safety monitoring committee (SMC).
This is a two-part Phase 1b, open-label study of ONT 10 administered in combination with
varlilumab. Two different doses of varlilumab will be studied in combination with the single
agent recommended dose of ONT 10. Intermediate and/or lower doses of varlilumab or ONT-10 may
also be studied at the recommendation of the safety monitoring committee (SMC). Treatment
will be administered in cycles of 12 weeks each. All patients will receive a single dose of
cyclophosphamide on Day -3. During Cycle 1, patients will receive ONT-10 administered SC once
per week for 8 weeks followed by ONT-10 once every 6 weeks starting with Cycle 2, in
combination with varlilumab administered IV once every 3 weeks x 3 doses, and then once every
6 weeks for cycles 2 through 5.
Each cohort will enroll an initial group of 6 evaluable patients with either breast or
ovarian carcinoma. Initial enrollment into a cohort will be staggered, with the first patient
treated in any new cohort to be followed for a minimum of two weeks for the occurrence of
Unacceptable Toxicity prior to enrollment of the remaining 5 patients. Subsequent enrollment
into a cohort may then continue without a staggered schedule until 6 patients treated are
considered evaluable. Up to 24 additional evaluable patients may be enrolled and treated in
Part 2 at the RD of varlilumab and ONT-10 identified in Part 1, including approximately equal
numbers of patients with breast carcinoma (n~12) and ovarian carcinoma (n~12). Treatment in
Part 2 will follow the same schedule as in Part 1.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05047926 -
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
|
N/A | |
| Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
| Recruiting |
NCT05733000 -
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04616534 -
Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT05368506 -
ZN-c3 for the Treatment of Metastatic Triple-Negative Breast Cancer and Advanced Ovarian Cancer
|
Early Phase 1 | |
| Active, not recruiting |
NCT00511992 -
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02650986 -
Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT05238831 -
SMMART Adaptive Clinical Treatment (ACT) Trial
|
Early Phase 1 | |
| Recruiting |
NCT05759923 -
First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients With Selected Advanced and/or Metastatic Solid Tumours
|
Phase 1 | |
| Active, not recruiting |
NCT02659241 -
Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Early Phase 1 | |
| Recruiting |
NCT06264921 -
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05472857 -
Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression
|
Phase 1 | |
| Recruiting |
NCT04575935 -
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
|
Phase 3 | |
| Active, not recruiting |
NCT04491942 -
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer
|
Phase 1 | |
| Recruiting |
NCT05969860 -
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
|
Phase 2 | |
| Recruiting |
NCT05092373 -
Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax
|
Phase 1 |