Clinical trials: HER2-positive Solid Tumors
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
PRS-343 in HER2-Positive Solid Tumors
A multi center, open-label, Phase 1 dose escalation study with expansion cohort is designed to determine the MTD, RP2D and dosing schedule of PRS-343 in patients with HER2+ advanced or metastatic solid tumors.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Bladder Cancer, HER2-positive Solid Tumor
- Trial name
- NCT03330561
- Testing
- PRS-343
- Where
- 10 sites in United States
- Volunteers
- 85 people
- Sponsor
- Pieris Pharmaceuticals, Inc.
Solid Tumor, Adult
HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
Primary objective: To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced…
- Trial name
- NCT05322720
- Testing
- EOC202, albumin-bound paclitaxel
- Volunteers
- 50 people
- Sponsor
- Taizhou EOC Pharma Co., Ltd.
Advanced Solid Tumor
Evaluating the Safety, Tolerability, and Pharmacokinetics of BAT1006
Primary objectives: To evaluate the safety and tolerability of BAT1006 in patients with advanced her2-positive solid tumors. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
- Trial name
- NCT05414136
- Testing
- BAT1006
- Where
- 2 sites in China
- Volunteers
- 37 people
- Sponsor
- Bio-Thera Solutions
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
HER2-positive
CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors
This is a first-in-human open-label study to evaluate the safety and tolerability, and manufacturing feasibility of anti-HER2 CAR-monocytes (CT-0525) in participants with locally advanced (unresectable) or metastatic solid tumors…
- Trial name
- NCT06254807
- Testing
- CT-0525
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Carisma Therapeutics Inc
HER-2 Positive Advanced Solid Tumors
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary…
- Trial name
- NCT05957536
- Testing
- D3L-001
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 128 people
- Sponsor
- D3 Bio (Wuxi) Co., Ltd
Solid Tumors
A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors
A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
- Trial name
- NCT02881138
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
HER2-Positive Solid Tumors
A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated…
- Trial name
- NCT04501770
- Testing
- Chort 1 of M802, Chort 2 of M802, Cohort 3 of M802
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Wuhan YZY Biopharma Co., Ltd.
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 260 people
- Sponsor
- Pfizer
Stomach Neoplasms, Solid Tumor
To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer
The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects…
- Trial name
- NCT06504732
- Testing
- IAH0968, Trastuzumab Injection
- Where
- 2 sites in China
- Volunteers
- 574 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Advanced Malignant Solid Tumors
A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors.
The objective of this study is to assess the safety and tolerability of MRG002 in combination with HX008 in patients with HER2-expressed advanced malignant solid tumors; and to , explore the maximum tolerated dose (MTD), and to…
- Trial name
- NCT05338957
- Testing
- MRG002+HX008
- Where
- 5 sites in China
- Volunteers
- 30 people
- Sponsor
- Shanghai Miracogen Inc.
HER2 Mutation-Related Tumors, HER2
A Phase 1/1b Study of IAM1363 in HER2 Cancers
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
- Conditions
- HER2 Mutation-Related Tumors, HER2, HER2-positive Breast Cancer, HER2 + Breast Cancer
- Trial name
- NCT06253871
- Testing
- IAM1363
- Where
- 53 sites in United States, France and 6 more
- Volunteers
- 383 people
- Sponsor
- Iambic Therapeutics, Inc
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
HER2 Expressing Solid Tumors
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
- Trial name
- SENTRY-HER2 (NCT07192432)
- Testing
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Vironexis Biotherapeutics Inc.