Betta Pharmaceuticals

Biomarkers

• EGFR exon 19 deletion / L858R5
• EGFR exon 20 insertion1
• MET exon 14 skipping1

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

befotertinib 3MCLA-129 3icotinib 1CFT8919 1

Trials

7 of 36 trials shown

1. Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

   Recruiting Phase 3 Betta Pharmaceuticals Started 2023Primary completion 2028-04 NCT06041776

   befotertinibicotinib

   …bors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

   EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-09-22Non-Small Cell Lung Cancer, EGFR Sensitive Mutation, Adjuvant Therapy

2. Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

   Recruiting Phase 1/2 Betta Pharmaceuticals Started 2026Primary completion 2028-12 NCT07435038

   BPI-572270

   Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.

   KRAS G12CKRAS G12DNon-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors

3. Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI

   Recruiting Phase 2 Betta Pharmaceuticals Started 2025Primary completion 2028-11 NCT07181499

   befotertinibpemetrexedcarboplatin

   …FR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);

   EGFR exon 19 deletion / L858RNSCLC, Adjuvant Drug Therapy, EGFR

4. Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.

   Not yet recruiting Phase 2 Betta Pharmaceuticals Started 2025Primary completion 2028-04 NCT06885840

   MCLA-129

   …Cohort 2: Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment which inclu…

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

5. Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

   Recruiting Phase 1/2 Betta Pharmaceuticals Started 2021Primary completion 2028-04 NCT04930432

   MCLA-129

   For patients with advanced NSCLC, EGFR positive is defined as: EGFR mutation or EGFR amplification.

   EGFR exon 19 deletion / L858REGFR exon 20 insertionMET exon 14 skippingSolid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer

6. A Phase I Study of CFT8919 in Patients With Advanced NSCLC

   Recruiting Phase 1 Betta Pharmaceuticals Started 2024Primary completion 2027-06 NCT06641609

   CFT8919

   …rmed locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR-L858R mutation, who have failed standard treatment (disease progression or intolerance), lack s…

   EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer With EGFR Mutation

7. Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation

   Not yet recruiting Phase 1 Betta Pharmaceuticals Started 2023Primary completion 2028-11 NCT06015568

   MCLA-129befotertinib

   …astatic NSCLC that is not suitable for radical surgery or radiotherapy, and harbored EGFR exon 19 deletion or exon 21 L858R mutation( either alone or in combination with other EGFR mutations) in N…

   EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-08-29Non-Small Cell Lung Cancer、EGFR Sensitive Mutation

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