Clinical Trials for Uterine Cancer

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

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 advanced or metastatic solid tumors that have progressed on at least three months of pembrolizumab, evaluating the investigational oral integrin αvβ8/αvβ1 inhibitor PLN-101095 as monotherapy or combined with pembrolizumab. Eligible patients must have no other effective treatment options and prior pembrolizumab resistance (primary or secondary).

ClinicalTrials.gov ID: NCT06270706

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant 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.

TrialFetch AI summary: Eligible patients are adults with advanced, HER2-expressing solid tumors (including gynecologic, urothelial, biliary tract, breast, lung, and gastrointestinal cancers) who have progressed after at least two prior lines of standard therapy. All participants receive BL-M07D1, an investigational HER2-directed antibody-drug conjugate that delivers a topoisomerase I inhibitor (Ed-04) selectively to tumor cells via IV infusion every 21 days.

ClinicalTrials.gov ID: NCT06293898

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced 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.

TrialFetch AI summary: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264

Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

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: HER2-expressing (IHC 1+/2+/3+) advanced or metastatic endometrial cancer after ≥1 prior systemic therapy, ECOG 0–2; prior anti‑HER2 allowed with reconfirmed HER2, treated/stable CNS disease permitted. Patients receive pembrolizumab plus lenvatinib with an autologous HER2-targeted dendritic cell vaccine (AdHER2DC), with one arm adding N‑803 (IL‑15 superagonist that expands/activates NK and CD8 T cells) to potentially enhance response to PD‑1 blockade; lenvatinib is dose‑de‑escalated to define RP2D.

ClinicalTrials.gov ID: NCT06253494

A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With 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.

TrialFetch AI summary: Adults with advanced, measurable solid tumors (ECOG 0–1) eligible for biopsy, including FRα‑expressing cancers such as ovarian, receive the investigational FRα‑targeted topoisomerase‑I ADC AZD5335 (torvutatug samrotecan) as monotherapy or combined with bevacizumab, carboplatin (± bevacizumab), or PARP1‑selective inhibitors (saruparib or AZD9574). Aimed at patients who have exhausted standard options, with exclusions for uncontrolled CNS disease and significant comorbidities; early data suggest higher activity in FRα‑high tumors.

ClinicalTrials.gov ID: NCT05797168

A Phase IB/II Multi-Cohort Study of Targeted Agents and/or Immunotherapy With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer

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: Biomarker-driven platform for adults with recurrent/persistent endometrial carcinoma after 1–2 prior lines, assigning patients by FoundationOne CDx to targeted doublets with or without the PD‑L1 inhibitor atezolizumab. Active cohorts include atezolizumab plus talazoparib for high genomic LOH, atezolizumab plus anti‑TIGIT tiragolumab for MSI‑H/high TMB tumors, inavolisib (PI3Kα inhibitor) plus letrozole for PIK3CA‑mutant tumors without PTEN/AKT1 alterations, and giredestrant (oral SERD) plus abemaciclib for ER‑positive, RB1‑intact disease.

ClinicalTrials.gov ID: NCT04486352

A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN00-3694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer

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 recurrent clear cell or endometrioid ovarian carcinoma, platinum‑resistant HGSOC (dose‑escalation only), or recurrent FIGO grade 1 endometrioid/clear cell endometrial carcinoma receive oral tuvusertib (ATR inhibitor) plus ZEN‑3694 (pan‑BET inhibitor), with biomarker‑driven expansion enrolling both ARID1A‑mutated and ARID1A‑wild‑type cohorts. Aims include defining RP2D and assessing safety and preliminary activity, with mandated biopsies to explore pharmacodynamic effects and ARID1A‑related response.

ClinicalTrials.gov ID: NCT05950464

Phase I/IB Study of Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

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 recurrent high-grade uterine/endometrial cancers (FIGO grade 3 endometrioid, serous, mixed high-grade, or carcinosarcoma) after platinum, ECOG 0–2, measurable disease, and prior HER2- or immune-therapy as appropriate, receive paclitaxel plus zanzalintinib (XL092), an oral multi-targeted TKI inhibiting VEGFR2, MET, and TAM kinases, with maintenance zanzalintinib for responders/stable disease. Excludes prior TKIs/bevacizumab, uncontrolled CV disease, high-risk bleeding/GI conditions, and untreated/unstable CNS disease.

ClinicalTrials.gov ID: NCT06795009

Pragmatic Pilot Study of ctDNA Informed Immune Checkpoint Inhibitor De-escalation in Advanced/Recurrent Mismatch Repair Deficient (MMR-D)/Microsatellite Instability High (MSI-H) Endometrial Cancer Using Standard of Care Treatments

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with stage III (residual), stage IV, or recurrent MMR-D/MSI-H endometrial carcinoma eligible for standard first-line chemotherapy plus immune checkpoint inhibitor (no prior PD-1/PD-L1/CTLA-4 therapy; treated/stable brain metastases allowed). All receive usual chemo-immunotherapy and maintenance ICI, with a ctDNA blood test at ~1 year used to guide de-escalation: ctDNA-negative patients consider stopping maintenance ICI while ctDNA-positive patients continue maintenance ICI per standard care.

ClinicalTrials.gov ID: NCT07270666

An Open-label, Phase 1a/1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and/or Refractory 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.

TrialFetch AI summary: Enrolls adults with ECOG 0–1 and advanced relapsed/refractory solid tumors after standard therapy; dose escalation includes broad solid tumors including primary CNS tumors, while expansion focuses on ovarian cancer, endometrial cancer, and cholangiocarcinoma. Treatment is PHST001, a humanized IgG4 anti-CD24 antibody intended to block CD24–Siglec-10 innate immune checkpoint signaling and enhance macrophage phagocytosis, given as monotherapy or with chemotherapy backbones such as paclitaxel, topotecan, doxorubicin, FOLFIRI, FOLFOX, or gemcitabine.

ClinicalTrials.gov ID: NCT06840886