Phase I Study of SYD985 With Niraparib in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04235101|
Recruitment Status : Not yet recruiting
First Posted : January 21, 2020
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: SYD985 + Niraparib||Phase 1|
This is an open-label, single-arm study in which patients with HER2-expressing locally advanced or metastatic solid tumours will be treated with both an anti-body drug conjugate SYD985 and a Poly (ADP-ribose) Polymerase (PARP) inhibitor niraparib. SYD985 is an antibody-drug conjugate and consists of two parts. The antibody part binds to a protein that exists on different types of cancer cells (HER2 protein). When SYD985 binds to this protein, it will be taken up by the cancer cell. The second part of the drug, a toxin, will be cleaved in the cell and subsequently kills the cancer cell. Niraparib blocks the action of enzymes PARP-1 and PARP-2, which help to repair damaged DNA in cells when the cells divide to make new cells. By blocking PARP enzymes, the damaged DNA in cancer cells cannot be repaired, and, as a result, the cancer cells die.
Part 1 includes patients with locally advanced or metastatic HER2-expressing solid tumours of any origin that showed progression on standard therapy or for whom no standard therapy exists. Patients will receive SYD985 infusions every three weeks in combination with niraparib until progression of the cancer or unacceptable toxicity develops. In this first part of the study, different doses of niraparib will be given for either 1, 2 or 3 weeks.
Part 2 includes patients with advanced or metastatic breast, ovarian or endometrial cancer that showed progression on standard therapy or for whom no standard therapy exists. Patients will receive SYD985 infusions every three weeks in combination with niraparib until progression of the cancer or unacceptable toxicity develops.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two-part Phase I Study With the Antibody-drug Conjugate SYD985 in Combination With Niraparib to Evaluate Safety, Pharmacokinetics and Efficacy in Patients With HER2-expressing Locally Advanced or Metastatic Solid Tumors.|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: SYD985 + Niraparib
SYD985, Intravenous, every 3 weeks (Q3W) Niraparib taken orally and either 100 mg, 200 mg or 300 mg once daily for either 1, 2 or 3 weeks.
Drug: SYD985 + Niraparib
SYD985 powder for concentrate for solution for infusion Niraparib 100 mg per hard capsule
Other Name: (vic-)trastuzumab duocarmazine + Zejula
- Objective Response Rate (ORR) [ Time Frame: 2 years ]Objective response rate is defined as the proportion of patients with an assessed best overall response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Progression-Free Survival (PFS) [ Time Frame: 2 years ]Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier.
- Overall Survival (OS) [ Time Frame: 2-year overall survival ]Overall survival is defined as the time from date of randomization to death due to any cause.
- Incidence of Treatment-Emergent Adverse Events (AEs) [ Time Frame: 2 years ]AEs will be graded by the investigator as assessed by CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235101
|Contact: Norbert Koper||+31 24 372 email@example.com|
|Study Director:||Norbert Koper||Synthon Biopharmaceuticals BV, The Netherlands|