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PT-112

Phase 1

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 18, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

PT-112 · 1 trial · 1 indication

Phase 1 1
NCT03409458A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With AvelumabNon-Small Cell Lung Cancer (NSCLC)
COMPLETED68 Analytics
PHASE1COMPLETED
A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Non-Small Cell Lung Cancer (NSCLC)Unlock trial analytics

Study Endpoints

Primary Endpoints

NSCLC Cohort: Evaluate best overall response rate (ORR) by tumor type according to Immune-Response Criteria (iRECIST) in metastatic or locally advanced, squamous or non-squamous NSCLC.
24 months

Secondary Endpoints

NSCLC Cohort: Confirm the RP2D patients with metastatic or locally advanced, squamous or non-squamous NSCLC
24 months
NSCLC Cohort: Assess the safety profile of PT-112 in combination with avelumab
24 months
NSCLC Cohort: Evaluate disease control rate (CR, PR and SD lasting ≥6 months) overall and by tumor type based on iRECIST
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PT-112 in combination with avelumabEXPERIMENTALPT-112, administered by intravenous infusion avelumab, administered by intravenous infusion Patients with all listed conditions are eligible for treatment during the dose escalation phase of the study. Patients with NSCLC are eligible for the dose confirmation phase of the study.

Interventions

NameTypeDescription
PT-112DRUGThe RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort. For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15.
avelumabBIOLOGICALAvelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients ...

Countries:United StatesSwitzerland
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Frequently asked questions about PT-112

What is PT-112 used for in Non-Small Cell Lung Cancer (NSCLC)?

PT-112 is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in patients.

Who makes PT-112?

PT-112 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's potential as a treatment for Non-Small Cell Lung Cancer (NSCLC).

What phase is PT-112 in?

PT-112 is in Phase 1 clinical development. It is an investigational drug being studied for Non-Small Cell Lung Cancer (NSCLC) and has not been approved by the FDA or other regulatory agencies. Its safety and efficacy are still being evaluated in early-stage trials.

What clinical trials is PT-112 in?

PT-112 has been studied in one clinical trial, identified as NCT03409458. This was a Phase 1 dose escalation and confirmation study of PT-112 in combination with avelumab for advanced solid tumors, including Non-Small Cell Lung Cancer (NSCLC). The trial, which enrolled 68 participants, has been completed.

Is PT-112 the same as avelumab?

No, PT-112 is not the same as avelumab. PT-112 is an investigational small molecule being developed by Pfizer, while avelumab is a separate cancer immunotherapy. In the clinical trial NCT03409458, PT-112 was studied in combination with avelumab for the treatment of Non-Small Cell Lung Cancer (NSCLC).