Clinical Trials for Uterine Cancer

A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with metastatic or recurrent HPV16-positive cancers (e.g., cervical, oropharyngeal, anal, vulvar, vaginal, penile) who are HLA-A*02:01–positive receive lymphodepleting cyclophosphamide/fludarabine, a single infusion of autologous T cells engineered with a high-avidity TCR targeting HPV16 E7(11–19), followed by high-dose IL-2. Designed for patients post standard therapy or who declined it; controlled brain metastases allowed.

ClinicalTrials.gov ID: NCT05686226

A Biomarker Study of the Wee1 Inhibitor Azenosertib (ZN-c3) in Women With Recurrent or Persistent Uterine Serous Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Single-arm study of azenosertib (ZN‑c3), an oral WEE1 kinase inhibitor that abrogates the G2/M checkpoint and increases replication stress, in adults with recurrent or persistent uterine serous carcinoma after prior platinum therapy (MSI-H/dMMR patients should have received or be ineligible for PD-1/PD-L1 therapy). Requires measurable disease and biopsiable lesion for paired biopsies; assesses antitumor activity and biomarker correlations, with intermittent oral dosing on Days 1–5, 8–12, and 15–19 each cycle.

ClinicalTrials.gov ID: NCT06369155

RESOLVE: letRozole abEmaciclib combinationS in endOmetriaL and oVarian cancEr: A Multi-Cohort Phase 2 Study of Letrozole/Abemaciclib Alone and in Combination With Metformin, Zotatifin and Gedatolisib

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with recurrent/metastatic or treatment‑resistant endometrial cancer (primarily ER+) or low‑grade serous ovarian/fallopian tube/peritoneal carcinoma (ER+ preferred; ER‑ allowed in LGSOC) receive abemaciclib with letrozole, alone or combined with agents targeting PI3K/mTOR/DNA‑PK (samotolisib/LY3023414), pan‑class I PI3K/mTORC1/2 (gedatolisib), translational control via eIF4A (zotatifin), or metabolic/AMPK pathways (metformin). Most cohorts require ECOG 0–1, measurable disease, adequate organ function, and endocrine sensitivity markers; one cohort allows prior CDK4/6 inhibitor exposure.

ClinicalTrials.gov ID: NCT03675893

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Single-arm study of lifileucel, an autologous tumor-infiltrating lymphocyte (TIL) therapy delivered after lymphodepleting chemotherapy and high‑dose IL‑2, in adults with advanced endometrial carcinoma (including carcinosarcoma) who have progressed after platinum chemotherapy and anti–PD‑1/PD‑L1 therapy, with at least one resectable lesion for TIL manufacture and one measurable lesion. Excludes uterine sarcomas and requires ECOG 0–1 and adequate organ function.

ClinicalTrials.gov ID: NCT06481592

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adult women with measurable recurrent or persistent uterine serous carcinoma after prior platinum chemotherapy and PD-(L)1 therapy (HER2-positive must have received HER2 therapy if eligible) receive oral azenosertib (ZN‑c3), a selective WEE1 kinase inhibitor. Single-arm study excludes prior WEE1/ATR/CHK1/2 inhibitors; efficacy assessed by RECIST with attention to GI and hematologic toxicities.

ClinicalTrials.gov ID: NCT04814108

A Phase 2 Study of ACR-368 Therapy in Subjects With Endometrial Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Biomarker-driven study in adults with recurrent/metastatic high‑grade endometrial cancer post platinum and anti–PD-(L)1, testing the CHK1/CHK2 inhibitor prexasertib (ACR‑368) either alone in OncoSignature-positive tumors or with ultra–low‑dose gemcitabine in OncoSignature‑negative or unselected patients. Requires measurable disease, ECOG 0–1, adequate organ function; key exclusions include symptomatic brain mets and prior CHK1 inhibitor exposure.

ClinicalTrials.gov ID: NCT05548296

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced/metastatic solid tumors (endometrial, gastric, mCRPC, ovarian, colorectal, urothelial, biliary) receive datopotamab deruxtecan (anti‑TROP2 antibody–drug conjugate delivering a topoisomerase I inhibitor) as monotherapy or combined with agents such as capecitabine/5‑FU, bevacizumab ± platinum, prednisone (mCRPC), platinum in urothelial cancer, or bispecific PD‑1/CTLA‑4 (volrustomig) or PD‑1/TIGIT (rilvegostomig) immunotherapies. Key exclusions include active/untreated CNS disease, prior TROP2- or deruxtecan-based ADCs, significant ILD/pneumonitis history, and uncontrolled infections/comorbidities.

ClinicalTrials.gov ID: NCT05489211

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial evaluates MDNA11, an IL-2 Superkine targeting the IL-2 beta receptor to enhance anti-tumor immunity, administered alone or with pembrolizumab, in adult patients with locally advanced or metastatic solid tumors. Eligible patients must have an ECOG performance status of 0 or 1 and adequate organ function.

ClinicalTrials.gov ID: NCT05086692

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults (and selected adolescents) with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation, who have progressed after at least one prior therapy, to receive rezatapopt (PC14586)—a selective oral p53 reactivator targeting the Y220C mutant—as monotherapy. Patients must have ECOG 0-1 and measurable disease; cohorts include ovarian, lung, breast, endometrial, and other solid tumors, with KRAS wild-type status required for some.

ClinicalTrials.gov ID: NCT04585750

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Eligible patients are adults with locally advanced or metastatic solid tumors (including ovarian, endometrial, non-small cell lung, breast cancer, and mesothelioma) who have progressed after standard therapies, with cohorts defined by tumor type, platinum sensitivity, and folate receptor alpha (FRα) status. The trial investigates Rina-S (rinatabart sesutecan), a folate receptor alpha-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, as monotherapy and in combination with carboplatin, bevacizumab, or pembrolizumab depending on cohort.

ClinicalTrials.gov ID: NCT05579366