Trials / Withdrawn
WithdrawnNCT04602117
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
ISPY-P1.01: Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer: A Phase I/Ib Trial
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- QuantumLeap Healthcare Collaborative · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
Detailed description
The study contains 2 cohorts. Cohort A is a 3+3 de-escalation cohort. Participants with certain HER-positive advanced solid tumors or HER2-low breast cancer will be enrolled in this cohort. Eligible participants will receive infusions of SYD985 every three weeks and of paclitaxel weekly. Participants will be monitored for safety and for the occurance of DLTs. Cohort B dose expansion will proceed at the identified dose from Cohort A (RP2D). Cohort B will only enroll patients with HER2-positive or HER2-low breast cancer.
Conditions
- HER2-positive Breast Cancer
- HER2 Low
- SYD-985
- SYD985
- Vic-trastuzumab Duocarmazine
- Metastatic Cancer
- Metastatic Breast Cancer
- Metastatic Gastrointestinal Carcinoid Tumor
- Metastatic
- HER2 Low Breast Cancer
- GastroEsophageal Cancer
- Gastroesophageal Adenocarcinoma
- Endometrium Tumor
- Ovarian Cancer
- Ovarian Carcinoma
- HER2-positive Gastric Cancer
- HER2-positive Metastatic Breast Cancer
- HER2 Mutation-Related Tumors
- HER-2 Protein Overexpression
- HER2 Low HR Positive
- HR Positive
- Hormone Receptor-positive Breast Cancer
- Estrogen Receptor Positive Tumor
- Progesterone Receptor-positive Breast Cancer
- Triple Negative Breast Cancer
- Hormone Receptor Negative Breast Carcinoma
- Bladder Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vic-trastuzumab duocarmazine (SYD985) + paclitaxel | SYD985 (\[vic-\]trastuzumab duocarmazine) an antibody-drug conjugate or ADC being developed by Byondis B.V. (Nijmegen, The Netherlands), consists of the recombinant humanized anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab linked, via a cleavable linker, to the duocarmycin prodrug, seco-duocarmycin-hydroxybenzamide-azaindole or seco-DUBA, which has potent antineoplastic activity. Eligible patients will receive infusions of SYD985 every three weeks and of paclitaxel weekly. |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2021-11-17
- Completion
- 2021-11-17
- First posted
- 2020-10-26
- Last updated
- 2023-11-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04602117. Inclusion in this directory is not an endorsement.