Clinical trial · Interventional
PF-07104091 as a Single Agent and in Combination Therapy
PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-0704091 + Fulvestrant (post CDK4/6) | Drug | — | UNRESOLVED |
| PF-07104091 + Fulvestrant (post CDK4/6) | Drug | — | UNRESOLVED |
| PF-07104091 monotherapy dose escalation | Drug | — | UNRESOLVED |
| PF-07104091 monotherapy dose expansion (ovarian) | Drug | — | UNRESOLVED |
| PF-07104091 monotherapy dose expansion (SCLC) | Drug | — | UNRESOLVED |
| PF-07104091 + palbociclib + fulvestrant | Drug | — | UNRESOLVED |
| PF-07104091 + palbociclib + letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- PF-07104091
- description
- CDK2 monotherapy dose escalation
- interventionNames
- Drug: PF-07104091 monotherapy dose escalation
- type
- EXPERIMENTAL
- label
- PF-07104091 + palbociclib + fulvestrant
- description
- CDK2 + palbociclib + fulvestrant
- interventionNames
- Drug: PF-07104091 + palbociclib + fulvestrant
- type
- EXPERIMENTAL
- label
- PF-07104091 + palbociclib + letrozole
- description
- CDK2 + palbociclib + letrozole
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy) * Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting * Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog * Participants with cytological diagnosis of advanced/metastatic SCLC * Participants with or cytological diagnosis of advanced/metastatic NSCLC * Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven). * Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated * Performance Status 0 or 1 * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity Exclusion Criteria: * Participants with known symptomatic brain metastases requiring steroids * Participants with any other active malignancy within 3 years prior to enrollment * Major surgery within 3 weeks prior to study entry * Radiation therapy within 3 weeks prior to study entry. * Systemic anti cancer therapy within 4 weeks prior to study * Prior irradiation to \>25% of the bone marrow * Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness * Active COVID-19/SARS-CoV2 infection * Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results * Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease. * Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed. * Hypertension that cannot be controlled by medications * Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry. * Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091. * Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. * Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short * Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally * Previous high dose chemotherapy requiring stem cell rescue * Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable). * Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers * Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic * Serum pregnancy test positive at screening * Other medical or psychiatric condition
References
Publications (0)
Data not yet available