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BREAST: METASTATIC: TNBC: 1st/2nd Line: BNT327-02

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

TNBC, Triple negative breast cancer, IDC

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st or 2nd line

Investigational Agent

BNT327

Drug Class

Bispecific PD-L1/VEGF ADC

PI

Greg Vidal, MD, PhD

Sponsor

Biontech

Path

Triple negative

Key Eligibility Criteria Details
  • Confirmed locally recurrent inoperable or metastatic TNBC
  • 1st line or 2nd line. Can have received (neo)adjuvant therapy if >6 months have passed between end of therapy and development of recurrent/metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No symptomatic brain mets
  • No active autoimmune disease
  • No other cancer within 2 years
  • No poorly controlled diabetes
PROSTATE: METASTATIC: Castrate Sensitive: EvoPAR-PROSTATE01

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Prostate

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Saruparib

Drug Class

PARP inhibitor

PI

Brad Somer, MD

Sponsor

AstraZeneca

Path

Adenocarcinoma

Key Eligibility Criteria Details
  • Prostate adenocarcinoma which is de novo or recurrent and castrate sensitive
  • No small cell, neuroendocrine, sarcomatoid, spindle cell, or signet ring histology
  • Metastatic disease with clear evidence of at least 1 bone lesion and/or at least 1 soft tissue lesion that is assesable via CT or MRI
  • Receiving ADT with a GnRH analogue or has had bileteral orchiectomy
  • ECOG PS 0-1
  • Confirmed HRRm status by central tumor tissue and/or ctDNA test
  • No history of another primary malignancy (with some exceptions per protocol)
  • No spinal cord compression or brain mets unless asymptomatic and not requiring steroids
ADVANCED SOLID TUMORS: Phase 1: Metastatic: BRCA or HRD mt: Late-line: XL309-101

An Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of XL309 (ISM3091) as Single-Agent and Combination Therapy in Patients With Advanced Solid Tumors

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Ovarian, Fallopian Tube, Prostate cancer, Pancreastic cancer, BRCA mutation

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

XL309

Drug Class

USP1 inhibitor

PI

Dan Vaena, MD

Sponsor

Exelixis

Path

BRCA mt

Key Eligibility Criteria Details
  • ECOG PS 0-1
  • Subjects who relapsed, progressed, or were intolerant to standard therapy, have a disease for which no therapy with a known overall survival benefit exists or are not a candidate for these therapies, and have one of the following cancers:

i. Histologically confirmed locally advanced/metastatic HER2-negative breast cancer, with deleterious or suspected deleterious BRCA1/2 mutation, that progressed on, was intolerant to, was refused, or ineligible for (PARPi).

ii. Histologically confirmed locally advanced/metastatic HGSOC (high-grade serous ovarian cancer), including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC), that progressed on, was intolerant to, refused, or ineligible to maintenance treatment with a PARPi.

iii. Histologically confirmed locally advanced/metastatic CRPC, with deleterious or suspected deleterious BRCA1/2 mutation, that progressed on, was intolerant to, refused, or ineligible for PARPi.

iv. Histologically confirmed locally advanced/metastatic pancreatic cancer with deleterious or suspected deleterious BRCA1/2 mutation that progressed on, was intolerant to, refused, or ineligible for maintenance treatment with a PARPi.

v. Locally advanced/metastatic tumors with deleterious or suspected deleterious germline or somatic HRR mutation or HRD phenotype.

Cohort-Expansion Stage Single Agent and Combination:

b) HER2-negative BRCAm Breast cancer cohort: i. Histologically confirmed locally advanced/metastatic HER2-negative Breast cancer with deleterious or suspected deleterious BRCA1/2 mutation have documented radiographic disease progression during or following their last systemic anticancer therapy and that progressed on, was intolerant to, refused, or ineligible for treatment with a PARPi.

c) Platinum-resistant HGSOC cohort: i. Histologically confirmed locally advanced/metastatic HGSOC, including primary peritoneal cancer (PPC) and fallopian tube cancer (FTC), that progressed on, was intolerant to, refused, or ineligible to maintenance treatment with a PARPi and who have platinum-resistant disease, defined by platinum free interval of less than 6 months ii. Platinum-refractory disease (progression on first-line treatment or within 4 weeks of completion) are excluded.

d) Platinum-sensitive HGSOC cohort - expansion combination only: i. Histologically confirmed locally advanced/metastatic HGSOC, including PPC and FTC, that progressed on, refused, or ineligible to maintenance treatment with a PARPi, and who have platinum-sensitive disease, defined by platinum free interval of more than 6 months e) mCRPC cohort: i. Subjects with metastatic, castration-resistant adenocarcinoma of the prostate with deleterious or suspected deleterious BRCA1/2 mutation, that progressed on, or was intolerant, refused, or ineligible to PARPi.

f) HRRm advanced solid tumors cohort: i. Locally advanced/metastatic tumors with deleterious or suspected deleterious germline or somatic HRR mutation or HRD phenotype.

  • No known symtomatic brain mets
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