Protocol Title: Phase 1/2, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a Monotherapy and in Combination with Nivolumab in Patients with Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications

Sponsor: Dragonfly Therapeutics

Protocol Number: DF9001-001

Key Criteria

§  Patient has advanced/metastatic solid tumor of epithelial origin with documented EGFR expression determined using IHC assay
§  Patient has histologically/cytologically confirmed locally advanced or metastatic solid tumor (HNSCC, NSCLC, CRC, Esophageal adenocarcinoma, gastric cancer, renal cell cancer, pancreatic cancer) where therapy has failed and has been confirmed to have EGFR expression
§  Must have at least 1 measurable lesion per RECIST 1.1

§  Disease specific criteria as follows:

Head and neck squamous cell cancer
o   Histologically/cytologically confirmed relapsed or metastatic cancer with confirmed EGFR expression via archival or fresh biopsy tissue
o   Radiographic disease progression while on/after receiving platinum-based chemotherapy and anti-PDL1 antibody
o   Must have fresh tumor biopsy during screening and on-treatment biopsy for PD analysis

Colorectal cancer
o   Histologically/cytologically confirmed relapsed or metastatic cancer with confirmed EGFR expression via archival or fresh biopsy tissue
o   Must have received one line of either FOLFOX, CAPOX, FOLFIRI, FOFOXFIRI with/without biological agent.
o   Must not have received anti-PDL1
o   Patient cannot be known mismatch repair (MMR)/MSI high
o   Must have radiographic disease progression while on/after treatment
o   Must have fresh tumor biopsy during screening and on-treatment biopsy for PD analysis

Non small cell lung cancer
o   Histologically confirmed cancer meeting criteria for stage IIIB, stage IV or recurrent disease with confirmed EGFR expression
o   Patient must have recurrent/progressive disease during/after first line combination therapy with checkpoint inhibitors and platinum-based chemo. Patient must not have received any subsequent line of therapy.
o   If patient has stage IIIB NSCLC, they must be considered ineligible for local therapies with curative intent (radiotherapy or surgery)
o   Patient must have received and progressed on anti PD L1 therapy
o   Actionable mutation status must be known
o   At least one tumor lesion accessible for fresh tumor biopsy
Excluded if
·         Patient has concurrent anticancer treatment
·         History of malignant disease within last three years (except basal/squamous cell carcinoma of skin, low grade prostate cancer, cervical carcinoma in situ)
·         Patient has brain metastasis (unless CNS lesion is asymptomatic, or previously treated or imaging is stable)
·         Patient is an organ transplant (autologous/allogenic stem cell) recipient
·         History of autoimmune disease requiring treatment with systemic immunotherapy
·         Patient has history of/active keratitis, ulcerative keratitis, corneal perforation, cardiopulmonary arrest, pulmonary fibrosis, ILD
·         Patient received anti-PD-L1 therapy previously and experienced severe toxicity

Talking Points

§  Study drug class: Natural killer cell engager therapy
§  Study design: Assess the maximum tolerated dose and overall response as monotherapy and in combination with Nivolumab in patients with advanced solid tumors.
§  Treatment will continue until patient’s disease progresses, patient experiences unacceptable toxicity or meets criteria for withdrawal
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