A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
A PHASE 1, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08098488 IN ADULT PARTICIPANTS WITH ADVANCED SOLID TUMORS.
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-08098488) in people with advanced solid tumors (cancer that cannot be removed with surgery or has spread to other parts of the body). PF-08098488 is being studied as a possible treatment for certain types of cancer. These include non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, and esophageal cancer. This study will also help researchers learn how the study medicine moves through and affects the body.
This study is seeking adults who:
- Have advanced non-small cell lung cancer, pancreatic cancer, stomach or gastroesophageal junction cancer, or esophageal cancer.
- Have received at least 1 previous treatment for their cancer.
- Have cancer that has grown, returned, or is no longer responding to available treatments.
All participants in this study will receive PF-08098488 as an IV infusion (given directly into a vein) at the study clinic. Researchers will study different dose levels and dosing schedules to find the dose that is safe and may work best. Participants will be monitored closely during treatment, especially after their first infusion. They may continue receiving the study medicine as long as their cancer is not getting worse and they are tolerating treatment.
The study includes a screening period of up to 28 days. Participants will have regular visits to the study clinic for treatment and health assessments. These assessments include scans to monitor the cancer and blood sample collection. Tumor tissue samples will also be collected when available or medically feasible. After treatment ends, participants will have a follow-up visit about 1 month later. They will then be contacted about every 12 weeks to check on their health.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Pfizer CT.gov Call Center
- 전화번호: 1-800-718-1021
- 이메일: ClinicalTrials.gov_Inquiries@pfizer.com
연구 장소
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Michigan
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Grand Rapids, Michigan, 미국, 49546
- 모병
- START Midwest, LLC
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Tennessee
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Nashville, Tennessee, 미국, 37203
- 모병
- Sarah Cannon Research Institute - Pharmacy
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Nashville, Tennessee, 미국, 37203
- 모병
- SCRI Oncology Partners
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Texas
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San Antonio, Texas, 미국, 78229
- 모병
- START San Antonio, LLC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years of age or older
- Advanced non-small cell lung cancer, pancreatic ductal adenocarcinoma, gastric cancer (including gastroesophageal junction carcinoma), or esophageal cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
- Measurable disease
- Must have received at least 1 prior approved systemic therapy:
- Part 1: progression or relapse following standard treatments and have no other appropriate standard of care option.
- Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting.
- Resolution of acute effects of prior anticancer therapy to baseline or Grade 1
- Consent to submit required pre-treatment tumor tissue as medically feasible
Exclusion Criteria:
- Received prior treatment with an antibody drug conjugate with an auristatin or microtubule inhibitor payload.
- Unacceptable renal, hepatic, hematologic, cardiologic, pulmonary, or abnormalities as defined by the protocol.
- Pre-existing sensory or motor neuropathy.
- Uncontrolled diabetes mellitus.
- Clinically significant and/ or symptomatic eye disease meeting protocol exclusion criteria.
- Pulmonary (lung) disease meeting protocol exclusion criteria.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Part 1 Dose Escalation
Different groups of participants will receive different doses and/or schedules of the study drug |
IV infusion |
|
실험적: Part 2 Dose Expansion
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1 |
IV infusion |
|
실험적: Part 2 Dose Optimization
Participants will be assigned to one of two dosing regimens deemed to be safe in Part 1 |
IV infusion |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Adverse Events (AEs)
기간: Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
|
Number of participants with AEs, characterized by type, frequency, severity, seriousness, and relationship to study intervention during the AE evaluation period. |
Start of study treatment to 30 days after the last dose of study drug administration or start of new anticancer therapy (whichever occurs first)
|
|
Part 1: Recommended Monotherapy Dose(s) for Expansion (RDEM)
기간: From first dose through completion of Part 1, an average of 1 year
|
From first dose through completion of Part 1, an average of 1 year
|
|
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Part 2: Recommended Monotherapy Dose for Further Development
기간: From first dose through completion of Part 2, an average of 2 years
|
From first dose through completion of Part 2, an average of 2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response Rate (ORR)
기간: From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
|
Percentage of participants with a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator. |
From baseline until first documented disease progression, death, or start of new anticancer therapy, whichever occurs first, up to approximately 3 years
|
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Duration of Response (DOR)
기간: From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. |
From the date of first objective response until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
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Progression Free Survival (PFS)
기간: From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
PFS as defined per RECIST 1.1. |
From first dose until disease progression or death due to any cause, whichever occurs first, up to approximately 3 years
|
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Overall Survival (OS)
기간: From first dose until death due to any cause, up to approximately 3 years
|
Time in weeks from the start of study treatment to date of death due to any cause. |
From first dose until death due to any cause, up to approximately 3 years
|
|
Maximum Observed Serum Concentration (Cmax)
기간: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
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Area under the concentration-time curve (AUC)
기간: From first dose through End of Treatment (EOT), up to approximately 3 years
|
From first dose through End of Treatment (EOT), up to approximately 3 years
|
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Time to Maximum Observed Serum Concentration (Tmax)
기간: From first dose through End of Treatment (EOT), up to approximately 3 years
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From first dose through End of Treatment (EOT), up to approximately 3 years
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Number of Participants With Anti-drug Antibody (ADA) against PF-08098488
기간: Start of study treatment to 30 days after last dose of study drug administration
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Start of study treatment to 30 days after last dose of study drug administration
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C6261001
- CEACAM5 EC4V (기타 식별자: Alias Study Number)
- 2026-527660-32-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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