Vic-trastuzumab duocarmazine (SYD985) + paclitaxel for Breast Cancer

Phase 1

Waitlist Available

Led By Paula R Pohlmann, MD, MSc, PhD

Research Sponsored by QuantumLeap Healthcare Collaborative

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for patients with specific types of advanced cancer. It aims to deliver medicine directly to cancer cells, making the treatment more effective and potentially reducing side effects.

Eligible Conditions

Ovarian Cancer
Breast cancer
Breast Cancer
Bladder Cancer
Tumors
Esophageal cancer
Human Rhinovirus
Uterine Fibroids
HER2 Negative
SYD-985 Syndrome
This is not a valid medical condition.
Trastuzumab-Duocarmazine
Cancer
Gastrointestinal Carcinoid Tumor
Gastroesophageal Adenocarcinoma
Gastric Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Benefit Rate (CBR) at 6 months

Common Toxicity Criteria for Adverse Events (CTCAE 5.0)

Overall response rate (ORR)

Secondary study objectives

Duration of response (DOR) of patients treated with the weekly paclitaxel with tri-weekly trastuzumab duocarmazine (SYD985) combination

Progression Free Survival (PFS) of patients treated with the weekly paclitaxel with tri-weekly trastuzumab duocarmazine (SYD985) combination

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vic-trastuzumab duocarmazine (SYD985) + paclitaxelExperimental Treatment1 Intervention

Single-arm, phase I trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel. The study contains 2 cohorts. Cohort A is the de-escalation cohort. Patients with certain HER-positive advanced solid tumors or HER2-low breast cancer will be enrolled in this cohort. Cohort B is the expansion cohort, in which only patients with HER2-positive or HER2-low breast cancer can be enrolled. Treatment will be administered on an outpatient basis.

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