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Antibody-drug Conjugate

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

Timeline

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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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

QuantumLeap Healthcare CollaborativeLead Sponsor
5 Previous Clinical Trials
6,977 Total Patients Enrolled
1 Trials studying Breast Cancer
5,000 Patients Enrolled for Breast Cancer
Byondis B.V.Industry Sponsor
9 Previous Clinical Trials
1,028 Total Patients Enrolled
Paula R Pohlmann, MD, MSc, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
73 Total Patients Enrolled
~0 spots leftby Oct 2025
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