NCT04261075

Brief Summary

The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2020

Typical duration for phase_1

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

January 7, 2020

Last Update Submit

August 12, 2022

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

  • Incidence of adverse events as a measure of safety

    The primary endpoint is safety as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs).

    From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months

  • Incidence of clinically significant laboratory values as a measure of safety

    Number of subjects with clinically significant laboratory values from baseline including blood counts, liver, kidney and pancreas tests, electrolytes, and blood clotting.

    From time of informed consent through 12 weeks after the last dose of investigational product, approximately 7 months

  • Incidence of clinically significant electrocardiogram (ECG) abnormalities as a measure of safety

    12 lead ECGs will be measured to identify clinical significant abnormalities including ECGs that demonstrate a QTcF value \>500ms, 2 additional 12-lead ECGs should be obtained over a 30 minute time period to confirm prolongation based on the average QTcF value

    From time of informed consent through treatment period and including the follow-up period 12 weeks after last dose of investigational product, approximatley 7 months

Secondary Outcomes (10)

  • OR (Objective Response; Response evaluation criteria in solid tumors [RECIST] v1.1)

    From time of consent until date of first documented disease progression (approximately 4 months)

  • DC (Disease Control; RECIST 1.1)

    From time of consent until date of first documented disease progression (approximately 4 months)

  • Half-life of IPH5201

    From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)

  • Maximum serum concentration (Cmax) of IPH5201

    From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)

  • Area under the curve (AUC) of IPH5201

    From start of treatment through Cycle 6 (21 day cycle, approximately 5 months)

  • +5 more secondary outcomes

Study Arms (3)

IPH5201 monotherapy dose escalation

EXPERIMENTAL

IPH5201 monotherapy

Biological: IPH5201

IPH5201 dose escalation with durvalumab

EXPERIMENTAL

IPH5201 plus durvalumab

Biological: IPH5201Biological: durvalumab

IPH5201 dose escalation with durvalumab + oleclumab

EXPERIMENTAL

IPH5201 plus durvalumab and oleclumab

Biological: IPH5201Biological: durvalumabBiological: oleclumab

Interventions

IPH5201BIOLOGICAL

Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years

IPH5201 dose escalation with durvalumabIPH5201 dose escalation with durvalumab + oleclumabIPH5201 monotherapy dose escalation
durvalumabBIOLOGICAL

Durvalumab Q3W for a maximum of 2 years

IPH5201 dose escalation with durvalumabIPH5201 dose escalation with durvalumab + oleclumab
oleclumabBIOLOGICAL

Oleclumab Q3W for a maximum of 2 years

IPH5201 dose escalation with durvalumab + oleclumab

Eligibility Criteria

Age18 Years - 101 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects; age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Subjects diagnosed with advanced solid tumors.
  • For Part 1 and Part 2 (IPH5201 in monotherapy or combined with durvalumab):Subjects must be refractory to standard therapy or for which no standard therapy exists.
  • For Part 3 (IPH5201 combined with durvalumab and oleclumab): Subjects must have received and radiologically progressed on 1 prior line of systemic therapy for metastatic pancreatic ductal adenocarcinoma.
  • Subjects must have at least 1 measurable lesion according to RECIST v1.1.
  • Subjects must provide tumor specimens .

You may not qualify if:

  • Receipt of any conventional or investigational anticancer therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies) within 21 days of the planned first dose.
  • Receipt of agents targeting CD73, CD39, or adenosine receptors.
  • Concurrent enrollment in another therapeutic clinical study.
  • Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent.
  • No toxicity leading to permanent discontinuation of prior IO therapy
  • Subjects must not have required the use of additional immunosuppression other than corticosteroids
  • Active or prior documented autoimmune or inflammatory disorders within the past 5 years
  • Cardiac and vascular criteria:
  • Presence of myocardial infarction or unstable angina , or stroke, within 6 months.
  • Congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension
  • History of severe hypertension
  • History of any grade of blood clot within 6 months
  • Active infection, including tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); or human immunodeficiency virus (HIV)
  • Uncontrolled illness including certain lung diseases, uncontrolled diabetes, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study.
  • Other invasive malignancy within 2 years.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Huntersville, North Carolina, 28078, United States

Location

Research Site

Providence, Rhode Island, 02906, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Bordeaux, 33076, France

Location

Research Site

Villejuif, 94805, France

Location

Research Site

Barcelona, 8035, Spain

Location

Research Site

Madrid, 28027, Spain

Location

Research Site

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

durvalumab

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

February 7, 2020

Study Start

March 3, 2020

Primary Completion

June 16, 2022

Study Completion

June 16, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)US(3)CH(1)FR(2)