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. 2021 Jun 24;22(13):6813. doi: 10.3390/ijms22136813

Table 2.

Ongoing currently trials in HER2-positive aCRC patients (clinicalTrials.gov Search Results 05/27/2021; key words: colorectal cancer, HER2).

Title of the Study/NCT Status/Phase Intervention Primary-Outcome Measures
1. A Study of Pyrotinib Combined with Capecitabine for Metastatic HER-2 Positive Colorectal Cancer/NCT04227041 Not yet recruiting/Phase I-II

  • Drug: Pyrotinib in combination with capecitabine

 MTD; PFS
2. A Clinical Study of Pyrotinib in Patients of Advanced Colorectal Cancer with Her2 Variation/NCT04380012 Recruiting/Phase II

  • Drug: Pyrotinib

  • Drug: Pyrotinib in combination with trastuzumab

 ORR
3. Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients with KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status/NCT03457896 Recruiting/Phase II

  • Drug: Trastuzumab;

  • Drug: Cetuximab

  • Drug: Neratinib

  • Diagnostic Test: Guardant360

 PFS
4. Trastuzumab Deruxtecan in Participants with HER2-overexpressing Advanced or Metastatic Colorectal Cancer/NCT04744831 Not yet recruiting/Phase II

  • Drug: DS-8201a 5.4 mg/kg Q3W

  • Drug: DS-8201a 6.4 mg/kg Q3W

 ORR
5. Study of Trastuzumab-emtansine in Patients with HER2- positive Metastatic Colorectal Cancer Progressing after Trastuzumab and Lapatinib (RESCUE)/NCT03418558 Unknown status/Phase II

  • Drug: Trastuzumab-emtansine

 ORR
6. Pyrotinib in Combination with Trastuzumab in Treatment- Refractory, HER2-positive Metastatic Colorectal Cancer/NCT03843749 Recruiting/Not Applicable

  • Drug: Pyrotinib

 ORR
7. Evaluation of Trastuzumab in Combination with Lapatinib or Pertuzumab in Combination with Trastuzumab-Emtansine to Treat Patients with HER2-positive Metastatic Colorectal Cancer (HERACLES)/NCT03225937 Unknown status/Phase II

  • Drug: Trastuzumab, Lapatinib

  • Drug: Pertuzumab, trastuzumab-emtansine

 ORR
8. Monoclonal Antibody Plus Chemotherapy in Treating Patients with Advanced Colorectal Cancer That Overexpresses HER2/NCT00003995 Completed/Phase II

  • Biological: trastuzumab

  • Drug: irinotecan hydrochloride

 ORR
9. Tucatinib Plus Trastuzumab in Patients with HER2+ Colorectal Cancer (MOUNTAINEER)/NCT03043313 Recruiting/Phase II

  • Drug: Trastuzumab

  • Drug: Tucatinib

 cORR
10. A Phase 1 Study of SHR-A1811 in Patients with Selected HER2 Expressing Tumors/NCT04513223 Not yet recruiting/Phase I

  • Drug: SHR-A1811

 DLT; RP2D
11. S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients with Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery/NCT03365882 Recruiting/Phase II

  • Biological: Cetuximab

  • Drug: Irinotecan Hydrochloride

  • Other: Laboratory Biomarker Analysis

  • Biological: Pertuzumab, Trastuzumab

  • Device: HER-2 testing

 PFS
12. Vaccine Therapy in Treating Patients with Stage IIB, Stage III, or Stage IV Colorectal Cancer/NCT00091286 Terminated/Early Phase I

  • Biological: HER-2-neu, CEA peptides, GM- CSF, Montanide ISA-51 vaccine

 Safety
13. Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System/NCT03185988 Recruiting/Phase II

  • Drug: chemotherapy in combination with trastuzumab for arm1, arm2, arm3, arm 4

 ORR
14. A Study of Poziotinib in Patients with EGFR or HER2 Activating Mutations in Advanced Malignancies/NCT04172597 Recruiting/Phase II

  • Drug: Poziotinib Hydrochloride

 ORR
15. Safety and Preliminary Efficacy of SNK01 in Combination with Trastuzumab or Cetuximab in Subjects with Advanced HER2 or EGFR Cancers/NCT04464967 Not yet recruiting/Phase I-II

  • Biological: SNK01

  • Drug: Trastuzumab, Cetuximab

 RP2D; ORR
16. A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer/NCT02713984 Withdrawn/Phase I-II

  • Biological: Anti-HER2 CAR-T

 CTCAE
17. Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for the Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, the DASH trial/NCT04704661 Not yet recruiting/Phase I

  • Drug: Ceralasertib

  • Biological: Trastuzumab Deruxtecan

 AEs (For Escalation Phase); RP2D
18. Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers/NCT04430738 Recruiting/Phase I-II

  • Drug: tucatinib

  • Drug: trastuzumab

  • Drug: oxaliplatin

  • Drug: leucovorin

  • Drug: fluorouracil

  • Drug: capecitabine

 Renal dose-limiting toxicities; AEs; laboratory abnormalities.
19. Binary Oncolytic Adenovirus in Combination with HER2- Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors/NCT03740256 Recruiting/Phase I

  • Biological: CAdVEC

 DLT
20. CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors/NCT04660929 Recruiting/Phase I

  • Biological: CT-0508

 Safety and tolerability.
21. Study of A166 in Patients with Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene/NCT03602079 Recruiting/Phase I-II

  • Drug: A166

 MTD
22. Intravenous TAEK-VAC-HerBy Vaccine Alone and in Combination Treatment in HER2 Cancer Patients/NCT04246671 Recruiting/Phase I-II

  • Biological: TAEK-VAC-HerBy

 DLT
23. Phase I/II Trial of Antagonism of HER in GI Cancer/NCT04246671 Completed/Phase I-II

  • Drug: AZD8931

  • Drug: Irinotecan

  • Drug: Folinic Acid

  • Drug: Fluorouracil

 DLT
24. Lapatinib and Cetuximab in Patients with Solid Tumors/NCT01184482 Completed/Phase I

  • Drug: cetuximab, lapatinib

 MTD
25. FATE-NK100 as Monotherapy and in Combination with Monoclonal Antibody in Subjects with Advanced Solid Tumors/NCT03319459 Active, not recruiting/Phase I

  • Drug: FATE-NK100

  • Drug: Cetuximab

  • Drug: Trastuzumab

 ORR
26. A Study of SBT6050 Alone and in Combination with Pembrolizumab in Patients with Advanced HER2 Expressing Solid Tumors/NCT04460456 Recruiting/Phase I

  • Drug: SBT6050

  • Drug: pembrolizumab

 DLT; AEs
27. A Dose Finding Study of ZW49 in Patients with HER2-Positive Cancers/NCT03821233 Recruiting/Phase I

  • Drug: ZW49

 DLT; AEs
28. ACE1702 in Subjects with Advanced or Metastatic HER2- expressing Solid Tumors/NCT04319757 Recruiting/Phase I

  • Drug: ACE1702

  • Drug: Cyclophosphamide

  • Drug: Fludarabine

 DLT; SAEs; MTD
29. A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer/NCT03929666 Recruiting/Phase II

  • Drug: ZW25 (Zanidatamab)

  • Drug: Capecitabine

  • Drug: Cisplatin

  • Drug: Fluorouracil

  • Drug: Leucovorin

  • Drug: Oxaliplatin

  • Drug: Bevacizumab

  • Drug: Gemcitabine

 DLT; CTCAE;
ORR
30. A First-in-human Study Using BDC-1001 in Advanced HER2-Expressing Solid Tumors/NCT04278144 Recruiting/Phase I-II

  • Drug: BDC-1001

  • Drug: Pembrolizumab

 SAEs; DLT; MTD; ORR
31. Study of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer/NCT00959946 Terminated/Phase I-II

  • Drug: Bosutinib

  • Drug: Capecitabine

 MTD; SAEs; ORR
32. Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer/NCT02318901 Terminated/Phase I-II

  • Drug: Pembrolizumab

  • Drug: Trastuzumab

  • Drug: ado-trastuzumab emtansine

  • Drug: Cetuximab

 RP2D
33. Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics (VISIONARY)/NCT04584008 Recruiting/Not Applicable

  • Drug: FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK- TKI, and etc.

  • Drug: Other Therapy

 ORR
34. A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01)/NCT04639219 Recruiting/Phase II

  • Drug: Trastuzumab deruxtecan

 ORR
35. A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients with Advanced Solid Tumors (MasterKey-01)/NCT04209465 Recruiting/Phase I-II

  • Drug: BDTX-189

 RP2D; ORR
36. A Study of SGN-CD228A in Advanced Solid Tumors/NCT04042480 Recruiting/Phase I

  • Drug: SGN-CD228A

 MTD; SAEs; ORR

AEs: adverse events; CTCAE: Common Toxicity Criteria for Adverse Effects; cORR: confirmed objective response rate; DLT: dose-limiting toxicity; MTD: maximally tolerated Dose; PFS: progression free survival; ORR: objective response rate; RR: response rate; RP2D: recommended Phase 2 dose; SAEs: Serious Adverse Events.