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IPH5201

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Aug 15, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

IPH5201 · 1 trial · 1 indication

Phase 1 1
NCT04261075IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.Advanced Solid Tumors
COMPLETED57 Analytics
PHASE1COMPLETED
IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events as a measure of safety
From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months

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

Incidence of clinically significant laboratory values as a measure of safety
From time of informed consent through 12 weeks after the last dose of investigational product, approximately 7 months

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

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

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

Secondary Endpoints

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)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IPH5201 monotherapy dose escalationEXPERIMENTALIPH5201 monotherapy
IPH5201 dose escalation with durvalumabEXPERIMENTALIPH5201 plus durvalumab
IPH5201 dose escalation with durvalumab + oleclumabEXPERIMENTALIPH5201 plus durvalumab and oleclumab

Interventions

NameTypeDescription
IPH5201BIOLOGICALAscending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years
durvalumabBIOLOGICALDurvalumab Q3W for a maximum of 2 years
oleclumabBIOLOGICALOleclumab Q3W for a maximum of 2 years
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Eligibility Criteria

Age Range18 Years to 101 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * 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 therap...

Countries:United StatesFranceSpainSwitzerland
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about IPH5201

What is IPH5201 used for?

IPH5201 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated as a potential therapy for patients with advanced solid tumors.

What does IPH5201 target?

IPH5201 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating advanced solid tumors, though the exact mechanism of action has not been detailed.

Who makes IPH5201?

IPH5201 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.

What phase is IPH5201 in?

IPH5201 is currently in Phase 1 clinical development. It is an investigational drug and has not received approval from regulatory authorities. The Phase 1 trial has been completed, and the drug remains in the early stages of clinical investigation for advanced solid tumors.

What clinical trials is IPH5201 in?

IPH5201 has been studied in one clinical trial with the identifier NCT04261075. This Phase 1 trial evaluated IPH5201 as a monotherapy or in combination with durvalumab, with or without oleclumab, in subjects with advanced solid tumors. The trial enrolled 57 participants and has been completed.

Is IPH5201 the same as durvalumab or oleclumab?

No, IPH5201 is a distinct investigational drug. Durvalumab and oleclumab are separate agents that were used in combination with IPH5201 in a clinical trial. IPH5201 was studied both as a monotherapy and in combination with these other drugs, but it is not the same as either of them.