Clinical Trials

Verdi Oncology Research offers cutting-edge clinical trial opportunities through the oncology practices in the Verdi network*. Principal investigators and research nurses from our research center have access to numerous clinical trials that are investigating breakthrough cancer therapies. *Trials vary by practice.

Phase 1: Advanced or Metastatic Solid Tumors (AB248-101)

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Sponsor:
Asher Biotherapeutics, Inc.
Trial:
AB248-101 An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors >NCT05653882 Eligibility: Patient must have advanced or metastatic melanoma, renal cell carcinoma, non-small cell lung cancer or squamous cell carcinoma head and neck cancer.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1: Advanced, Relapsed, Refractory, or Metastatic Malignancies (LVGN7409-101)

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Sponsor:
Lyvgen Biopharma Holdings, Limited
Trial:
LVGN7409-101 An Open Label, First in Human (FIH), Phase 1a/1b Trial of LVGN7409 (CD40 agonist antibody) as a Single Agent, in Combination with LVGN3616 (anti-PD-1 antibody), and in Combination with LVGN3616 and LVGN6051 (CD137 agonist antibody) in Patients with Locally Advanced, Relapsed, Refractory, or Metastatic Malignancy NCT04130542 > Key Eligibility: Enrolling solid tumors and lymphoma. Must have refractory, intolerant to standard of care, or no standard of care exists; may have measurable or evaluable disease. Prior therapy with anti-CD40 therapy. Exclusions: Grade 3 drug toxicity with prior immunotherapies; clinically significant cardiac condition within 6 months; uncontrolled pleural effusion, pericardial effusion, or recurrent ascites drainage; no history of stroke within 6 months
Contact:
Contact Clinical Research Project Manager, Karyn Burnworth – 765-446-5111, extension 19153; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1/2: Advanced Malignancies (BT8009-100)

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Sponsor:
BicycleTx Limited
Trial:
BT8009-100 Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies NCT04561362> Eligibility Criteria: Inclusions: Solid tumor expressing Nectin-4; Part C enrolls patients with decreased GFR; Exlusions: History of another malignancy within 3 years before first dose of BT8009 or residual disease from a previously diagnosed malignancy (with some exceptions), systemic IV anti-infective treatment or fever within the last 14 days prior to first dose of BT8009.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1/2: Advanced Solid Tumors (HB0036-01)

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Sponsor:
Shanghai Huaota Biopharmaceutical Co., Ltd.
Trial:
HB0036-01 A Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors NCT05417321> Key Eligibility: Exclusion: Patient on antibiotics <1 week in the last 28 days, alcohol abuse and cannabis abuse, concurrent malignancy, active or history of irAEs (like pneumonitis) or autoimmune disease, uncontrolled diabetes and hypertension
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Medical Food Study: Metastatic Colorectal Cancer (NEAAR-002)

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Sponsor:
Faeth Therapeutics
Trial:
NEAAR-002 Prospective Single Arm Medical Food Study to Evaluate a Standardized Nonessential Amino Acid Restriction (NEAAR) Medical Food for the Dietary Management of Metastatic Colorectal Cancer NCT05183295> Key Eligibility: Subjects ≥ 18 years old with histologically confirmed metastatic and unresectable CRC that has failed treatment for fluoropyrimidine and oxaliplatin ± BEV and have confirmation of tumor tissue of low expression of enzymes that manufacture serine/glycine and are eligible to begin treatment with FOLFIRI ± BEV.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Nashville Oncology Associates
    Nashville, TN

Phase 1: Metastatic Colorectal Cancer (ART-123.PN101)

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Sponsor:
Veloxis Pharmaceuticals, Inc.
Trial:
ART-123.PN101 A double-blind, placebo-controlled, randomized, dose-escalating, multicenter, Phase 1 study to assess the safety and tolerability of ART-123 in combination with leucovorin/5-FU /oxaliplatin and bevacizumab in mCRC NCT05251727> Key Eligibility: Patients with mCRC starting first line FOLFOX + Bevacizumab. Exclusion: History of bleeding or thromboembolic events due to risk of bleeding.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN
  • Verdi Cancer & Research Center of Texas
    Dallas, TX
  • Nashville Oncology Associates
    Nashville, TN

Phase 1/2: Advanced Solid Tumors (RNK05047-01)

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Sponsor:
Ranok Therapeutics Co. Ltd.
Trial:
RNK05047-01 A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Chaperone-mediated Protein Degrader RNK05047 in Subjects with Advanced Solid Tumors (CHAMP-1) NCT05487170> Key Eligibility: Phase 1: Any solid tumor and DLBCL. Inclusion: Refractory or intolerant to all available standard of care therapy; BMI > 18; creatinine clearance > 60 mL/min, INR < 1.5; PTT < ULN; Exclusion: Peripheral neuropathy > Grade 2.
Contact:
Contact Clinical Research Project Manager, Kirsten Becker – 765-446-5111, extension 19150; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1/2: Advanced Solid Tumors (CAL-ALT-803-02-17)

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Sponsor:
Altor BioScience
Trial:

CA-ALT-803-02-17

A phase 1/2 study of BA3071 in combination with nivolumab in patients with advanced solid tumors.

NCT05180799 >

Key Eligibility: Cohort 1 will enroll patients who have disease progression per RECIST v1.1 on or after single-agent checkpoint inhibitor therapy after experiencing an initial response (i.e., confirmed CR or PR by RECIST v1.1) while taking checkpoint inhibitor therapy. Patients will be enrolled into distinct cohorts (1c–1k) based on cancer type. For cohort 2, patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who have disease progression by RECIST v1.1 on a PD-1 checkpoint inhibitor after experiencing an initial confirmed CR or PR by RECIST v1.1 when they received checkpoint inhibitor as a single-agent for first-line treatment.

Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1B/2: Non-small Cell Lung Cancer (“Durga” Trial) (HS110-102)

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Sponsor:
Heat Biologics
Trial:

HS110-102

A Phase 1B/2 study of viagenpumatucel-l (HS110) in Combination with multiple treatment regimens in patients with non-small cell lung cancer (the: “durga” trial).

NCT02439450 >

Key Eligibility: Viagenpumatucel-L plus nivolumab-Refractory to prior immunotherapy (received less than 6 months of treatment) with 4 cohorts
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1/2: Advanced Solid Tumors (GLP-CDK-1009)

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Sponsor:
Gan & Lee Pharmaceuticals USA Corporation
Trial:

GLP-CDK-1009

An open-label, multicenter, phase 1b/2 study to establish safety, tolerability, and optimal dosing strategy of glr2007 in subjects with advanced solid tumors

NCT04444427 >

Key Eligibility: For Part 1 (Dose Escalation): Subjects with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit. For Part 1 (Dose Escalation): The subject must have histological or cytological evidence of cancer (a solid tumor) that is advanced and/or metastatic. For Part 2 (Dose Expansion): The subject must have histological or cytological evidence of 1 of the following cancers that is advanced and/or metastatic: Cohort A: ≥2L NSCLC Cohort B: ≥2L Brain metastases of breast or NSCLC origin Cohort C: First recurrence GBM

Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1/2: Advanced Solid Tumors (BA3071-001A)

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Sponsor:
BioAtla, Inc.
Trial:
BA3071-001 A phase 1/2 study of ba3071 in combination with nivolumab in patients with advanced solid tumors. NCT05180799 > Key Eligibility: Melanoma, mRCC, NSCLC, mUC, Gastric, SCLC, aHCC, Cervical. Must have first COVID vaccine with plan to receive 2nd vaccine per CDC guidelines is required. History of paracentesis excluded. History of hepatic encephalopathy excluded. Prior treatment with CLTA-4 inhibitor excluded. Supplemental oxygen use excluded.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1 Study: Advanced Solid Tumors and Lymphoma (TJ011133EDI101)

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Sponsor:
AbbVie/I-Mab Biopharma, Co, Ltd.
Trial:
TJ011133EDI101 A Phase 1 Study of TJ011133 Administered Alone or in Combination with Pembrolizumab or Rituximab in Subjects with Relapsed/Refractory Advanced Solid Tumors and Lymphoma NCT03934814 > Key Eligibility: Relapsed/refractory DLBCL, confirmed marginal zone or follicular lymphoma, or locally advanced NSCLC. NSCLC patients must have progressed on treatment with prior PDL1 inhibitor.
Contact:
Contact Clinical Research Project Manager, Kirsten Becker – 765-446-5111, extension 19150; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1 Study: Relapsed of Refractory Advanced Solid Tumors (TJ210001STM101)

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Sponsor:
AbbVie/I-Mab Biopharma, Co, Ltd.
Trial:
TJ210001STM101 A Phase 1 Study of TJ21001 Administered in Subjects with Relapsed or Refractory Advanced Solid Tumors NCT04678921 > Key Eligibility: Histologically confirmed advanced or metastatic cancer in patients who are refractory to or intolerant to all available therapy. Patients who received prior PD-1/PD-L1 checkpoint inhibitor or prior CTLA-4 inhibitor therapy may enroll if they did not experience Grade 3 immune-related toxicity.
Contact:
Contact Clinical Research Project Manager, Kirsten Becker – 765-446-5111, extension 19150; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1 Study: Advanced or Metastatic Solid Tumors (TJ033721STM101)

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Sponsor:
AbbVie/I-Mab Biopharma, Co, Ltd.
Trial:
TJ033721STM101 A Phase 1 Study of TJ033721 in Subjects with Advanced or Metastatic Solid Tumors NCT04900818 > Key Eligibility: Histologically confirmed advanced or metastatic solid tumor in subjects whose disease has progressed despite standard therapy, or who has no further standard therapy, or who is unsuitable for available standard treatment options. Subjects with HER2 positive esophagogastric cancer must have received prior anti-HER2 therapy, measurable disease.
Contact:
Contact Clinical Research Project Manager, Kirsten Becker – 765-446-5111, extension 19150; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1/2: Advanced Tumors (HH2710-G101)

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Sponsor:
Shanghai Haihe Pharmaceuticals Co, Ltd
Trial:
HH2710-G101 A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HH2710 in Patients with Advanced Tumors NCT04198818 > Key Eligibility: Histologically or cytological documented, unresectable/metastatic tumors that are refractory or intolerant to standard therapy or for whom no curative standard therapy exists.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Expansion Phase: Advanced Malignancies (AIS-B01)

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Sponsor:
Alpine Immune Sciences
Trial:
AIS-BO1 An Open-Label Study of ALPN-202 in Subjects with Advanced Malignancies (NEON-1) NCT04186637 > Key Eligibility: Expansion phase: Enrolling melanoma previously treated with at least 1 but no greater than 2 prior lines of systemic therapy, PDL1 positive cancers previously treated with at least 1 but no greater than 3 prior lines of therapy; and RCC.
Contact:
Contact Clinical Research Project Manager, Kirsten Becker – 765-446-5111, extension 19150; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1: Advanced or Metastatic Malignancy (LVGN6051-101)

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Sponsor:
Lyvgen Biopharma Holdings, Limited
Trial:
LVGN6051-101 An Open Label, First in Human (FIH), Phase 1 Trial of LVGN6051 as Single Agent and in Combination with Keytruda (pembrolizumab) in Advanced or Metastatic Malignancy NCT04130542 > Key Eligibility: Trial is currently enrolling patients in Phase 1b. Patients in the Phase 1b portion of the trial must have a histologically or cytologically confirmed melanoma, NSCLC, GI malignancy with MMR/MSI-H, or lymphoma that is metastatic or unresectable.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1: CLDN18.2 Positive Advanced Solid Tumors (LM302-01-101)

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Sponsor:
LaNova Medicines, Ltd.
Trial:
LM302-01-101 A Phase I, First-in-Human, Open-Label, Dose Escalation and Expansion Study of LM-302 in patients with CLDN18.2 Positive Advanced Solid Tumors. NCT05001516 > Key Eligibility: Any solid tumor; Phase 1a dose escalation: Measurable or non-measurable lesions. Excludes grade 2 peripheral neuropathy. Excludes patient with uncontrolled tumor-related pain. Phase 1b expansion requires CLDN18.2 positive.
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN

Phase 1: Hematologic Malignancies (VP-VTR-291-1101)

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Sponsor:
Vanda Pharmaceuticals, Inc.
Trial:
VP-VTR-291-1101 Phase 1 Multicenter, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose for Trichostatin A in Subjects with Relapsed or Refractory Hematologic Malignancies NCT03838926 > Key Eligibility: Hematological malignancies:  Acute Leukemia (AML, ALL), Myelodysplastic Syndrome (MDS), Chronic Myeloid Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin’s Lymphoma/Hodgkin’s disease (NHL/HL) that has relapsed or is refractory to standard therapy; currently only enrolling to MM, HL, NHL
Contact:
Contact Clinical Research Project Manager, Mariela Abad – 765-446-5111, extension 19165; [email protected]
Location:
  • Horizon Oncology and Research Center
    Lafayette, IN