AL8326 high dose group for Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Small Cell Lung CancerAL8326 high dose group - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat small cell lung cancer that has come back or spread. The goal is to see if it is safe and effective.

Eligible Conditions
  • Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 12 month

12 month
Objective Response Rates (ORR)
12 months
Duration of response ( DOR)
Number of participants with AEs, SAEs, abnormal physical examination findings, abnormal laboratory test results, abnormal vital signs and abnormal electrocardiography (ECG) findings
Optimal biological dose ( OBD )

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

OBD finding cohort at high dose
1 of 3
OBD finding cohort at middle dose
1 of 3
OBD finding cohort at low dose
1 of 3

Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: AL8326 high dose group · No Placebo Group · Phase 2

OBD finding cohort at high dose
Drug
Experimental Group · 1 Intervention: AL8326 high dose group · Intervention Types: Drug
OBD finding cohort at middle dose
Drug
Experimental Group · 1 Intervention: AL8326 middle dose group · Intervention Types: Drug
OBD finding cohort at low dose
Drug
Experimental Group · 1 Intervention: AL8326 low dose group · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month

Who is running the clinical trial?

Advenchen Pharmaceuticals, LLC.Lead Sponsor
Ramaswamy Govindan, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
10,758 Total Patients Enrolled
Saiama Waqar, MDPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
23 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female, 18 years of age or older.
You have no symptoms or signs of cancer.
You have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1.