AZD0171 for Locally Advanced or Metastatic Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Locally Advanced or Metastatic Solid TumorsAZD0171 - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new combination of drugs to treat pancreatic cancer.

Eligible Conditions
  • Locally Advanced or Metastatic Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: Up to 24 months

4 months
PFS at 4 months (PFS-4)
Day 28
Change from baseline in leukaemia inhibitory factor (LIF) bound to AZD0171 (total LIF)
Day 90
The PK profile of AZD0171, durvalumab and chemotherapy - Area under the concentration-time curve (AUC)
The PK profile of AZD0171, durvalumab and chemotherapy - Clearance (CL)
The PK profile of AZD0171, durvalumab and chemotherapy - Terminal elimination half-life (t1/2)
The PK profile of AZD0171, durvalumab and chemotherapy- Maximum observed plasma concentration (Cmax)
Day 28
Number of participants with change from Baseline in serum levels of carbohydrate antigen 19-9 (CA19-9)
Day 90
Number of participants with adverse events (AEs), immune mediated AEs (imAEs) and serious AEs (SAEs)
Up to 12 months
Overall survival at 12 months (OS-12)
Up to 24 months
Disease control rate (DCR)
Duration of response (DoR)
Median overall survival (OS)
Median progression free survival (PFS)
Objective response rate (ORR)
Participants with changes from Baseline in cluster of differentiation 8 (CD8+) T cell tumour infiltration in tumour samples
Day 90
Number of participants developing detectable anti-drug antibodies (ADAs) against AZD0171 and/or durvalumab in serum

Trial Safety

Safety Progress

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

Similar Trials

Trial Design

1 Treatment Group

AZD0171 + Durvalumab + chemotherapy
1 of 1

Experimental Treatment

115 Total Participants · 1 Treatment Group

Primary Treatment: AZD0171 · No Placebo Group · Phase 2

AZD0171 + Durvalumab + chemotherapyExperimental Group · 4 Interventions: AZD0171, Nab-paclitaxel, Gemcitabine, Durvalumab · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Gemcitabine
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,857,122 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must have at least 1 measurable lesion to be considered a target lesion according to RECIST v1.1.
You must consent to providing sufficient archival specimen taken during metastatic stage or fresh tumour specimens for tumoural CD8+ T cell testing for enrolment.
Presence of tumoural CD8+ T cells based on a predetermined benchmarked PDAC external sample.