Clinical Trials for Uterine Cancer

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)

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.

TrialFetch AI summary: Adults with B7-H4–positive recurrent/metastatic endometrial carcinoma or carcinosarcoma after platinum and anti–PD-1/PD-L1 therapy (≤2 prior lines) are randomized to the B7-H4–targeted antibody–drug conjugate puxitatug samrotecan (AZD8205, delivers a topoisomerase I inhibitor payload) every 3 weeks versus physician’s choice single-agent chemotherapy (doxorubicin or paclitaxel). Key exclusions include prior TOP1 inhibitor or B7-H4–targeted therapy, ILD/pneumonitis, and platinum-sensitive (>12 months) recurrence without subsequent platinum in the recurrent setting.

ClinicalTrials.gov ID: NCT07044336

A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)

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.

TrialFetch AI summary: For adults with pMMR advanced or recurrent endometrial carcinoma who have not progressed after first-line chemoimmunotherapy (carboplatin/taxane plus pembrolizumab), this trial randomizes maintenance pembrolizumab with or without sacituzumab tirumotecan. Sacituzumab tirumotecan is a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06952504

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

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.

TrialFetch AI summary: Adults with PD-L1 CPS ≥1 persistent/recurrent or newly metastatic cervical squamous/adenocarcinoma/adenosquamous carcinoma (ECOG 0–1) who complete standard first-line induction pembrolizumab + paclitaxel + platinum (with optional bevacizumab) without progression are randomized in maintenance to sacituzumab tirumotecan (MK-2870; TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload) plus pembrolizumab versus pembrolizumab alone, with bevacizumab allowed in either arm. The study tests whether adding MK-2870 improves PFS and OS and further characterizes safety/tolerability of the combination.

ClinicalTrials.gov ID: NCT07216703

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

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.

TrialFetch AI summary: Adults with recurrent or progressive endometrial carcinoma (excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) after 1–3 prior systemic lines including platinum-based chemotherapy and a PD-(L)1 inhibitor, with radiographic progression on/after most recent therapy. Randomized to rinatabart sesutecan (FRα-targeting antibody–drug conjugate delivering a topoisomerase I inhibitor payload) IV q3 weeks vs investigator’s choice single-agent paclitaxel or doxorubicin.

ClinicalTrials.gov ID: NCT07166094

A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent 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.

TrialFetch AI summary: Enrolls adult women with measurable recurrent endometrial cancer (including uterine carcinosarcoma) with central HER2 IHC 1+/2+ after ≥1 platinum regimen and prior anti–PD-1/PD-L1 (randomized 2:1) or HER2 IHC 3+ (single-arm), ECOG 0–2, and no prior topoisomerase I inhibitor/ADC exposure or significant ILD/pneumonitis. Treatment is the HER2-targeted antibody–drug conjugate BNT323/DB-1303 (anti-HER2 IgG1 linked to a cleavable topoisomerase I inhibitor payload) versus investigator’s choice single-agent chemotherapy (preferably doxorubicin or paclitaxel; docetaxel allowed).

ClinicalTrials.gov ID: NCT06340568

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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.

TrialFetch AI summary: This trial enrolls adults with recurrent or metastatic solid tumors—including endometrial, head and neck, pancreatic, colorectal, hepatocellular, gastric, urothelial, ovarian, cervical, biliary tract, certain subtypes of breast cancer, and cutaneous melanoma—whose disease has progressed after standard therapy and who have measurable, biopsiable disease. All patients receive ifinatamab deruxtecan, an investigational B7-H3-directed antibody-drug conjugate delivering a topoisomerase I inhibitor, administered intravenously every three weeks.

ClinicalTrials.gov ID: NCT06330064

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

TrialFetch AI summary: Adults with measurable, unresectable locally advanced or metastatic solid tumors that have progressed after standard therapies, enrolled in tumor-specific refractory cohorts (e.g., melanoma post–PD-(L)1, SCCHN post platinum/PD-(L)1, HER2-negative gastric/GEJ, HGS ovarian, cervical, endometrial, urothelial, ESCC, pancreatic, mCRPC, nonsquamous NSCLC without drivers, and HR+/HER2– breast cancer after CDK4/6 and chemo). Single-arm therapy is patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV q3w, an HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor (DXd).

ClinicalTrials.gov ID: NCT06172478

Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)

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.

TrialFetch AI summary: Single-arm study for adults with untreated recurrent, persistent, or metastatic cervical cancer (squamous, adeno, or adenosquamous) not amenable to curative therapy, ECOG 0–1, and no prior checkpoint inhibitor or systemic therapy for metastatic disease. Patients receive induction lorigerlimab (MGD019), a bispecific PD-1/CTLA-4 checkpoint inhibitor (DART IgG4) given IV every 3 weeks, with efficacy assessed by RECIST and close safety monitoring for immune-related AEs.

ClinicalTrials.gov ID: NCT05475171

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.

TrialFetch 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.

TrialFetch 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