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Antibody-drug Conjugate

Vic-trastuzumab duocarmazine (SYD985) + paclitaxel for Tumors

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

Study Summary

This trial is testing a new cancer drug that targets HER2 on the cell membrane. It is combined with paclitaxel, and the goal is to see if it is effective and safe.

Eligible Conditions
  • Tumors
  • Breast Cancer
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Benefit Rate (CBR) at 6 months
Common Toxicity Criteria for Adverse Events (CTCAE 5.0)
Overall response rate (ORR)
Secondary outcome measures
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

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
Byondis B.V.Industry Sponsor
9 Previous Clinical Trials
1,117 Total Patients Enrolled
Paula R Pohlmann, MD, MSc, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
73 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
2021. "ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04602117.
~0 spots leftby Apr 2025
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