Current Clinical Trials

Description:  Advanced Solid Tumors:   ABBV-400 as Monotherapy-A Global First-in-Human Study

Mechanism of Action: Antibody drug conjugate targeting c-MET with a topoisomerase inhibitor payload

Target Patient Population: All solid tumors

Study Design: Study drug is administered IV every 3 weeks

For more information on this trial, read its profile on clinicaltrials.gov here.

C-1400-01 (AGEN1777) (Agenus, Inc.)

Description:  A Phase 1 Study Investigating AGEN1777 as a Single-Agent and in Combination with PD-1 Inhibition in Patients With Advanced Solid Tumors

Mechanism of Action: bispecific antibody targeting TIGIT and CD96 (to enhance T and NK cell activation)

Target Population:  All solid tumors.  To be given as single agent or in combination with Balstilimab

Study Design:  Study drug is administered IV every 3 weeks.

ALKS 4230-003 (Alkermes Inc. )

Description:  Clinical and Immunologic Activity of Nemvaleukin Alfa With a less Frequent IV Dosing With Pembrolizumab and Impact on Tumor Microenvironment in Soloid Tumor Patients (Artistry-3)

Mechanism of Action:  IL2 receptor agonist

Target Patient Population: Cutaneous melanoma, Renal Cell, Triple Negative Breast, MMS Colorectal, Ovarian and any MSI-High solid tumors

Study Design: Study drug is administered IV every 3 weeks

Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

ALPN-202 – NEON-1 (Alpine Immune Sciences)

Description:  An open-Label Study of ALPN-202 In Subjects With Advanced Malignancies (NEON-1)

 Mechanism of Action: Inhibits PDL1 and CTLA4, engages CD28 co-stimulator.

Target Patient Population: Currently in expansion for Melanoma, Renal cell  and PDL1 positive cancers only

Study Design: Study drug is administered IV every 1 or 3 weeks

ALPN-202 – NEON-2 (Alpine Immune Sciences)

 Description:  An open-Label Study of ALPN-202 Combined With PD-1 Inhibition In Subjects With Advanced Malignancies (NEON-2)

Mechanism of Action: Inhibits PDL1 and CTLA4, engages CD28 co-stimulator in combination with Pembrolizumab.

Target Patient Population:.  All solid tumors

Study Design: Study drug is administered IV every 1 or 3 weeks

ALKS 4230-003 (Alkermes Inc. )

Description:  Clinical and Immunologic Activity of Nemvaleukin Alfa With a less Frequent IV Dosing With Pembrolizumab and Impact on Tumor Microenvironment in Soloid Tumor Patients (Artistry-3)

Mechanism of Action:  IL2 receptor agonist

Target Patient Population: Cutaneous melanoma, Renal Cell, Triple Negative Breast, MMS Colorectal, Ovarian and any MSI-High solid tumors

Study Design: Study drug is administered IV every 3 weeks

• • A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
  • PI: Amy VanderWoude
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor (SERENA-6)

Principal Investigator: Dr. Amy VanderWoude

For more information on this trial, read its profile on clinicaltrials.gov here.

• • • PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY
    • PI: Dr. Brinker

eFT226-0002 (Effector Therapeutics)

Description:  A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous Zotatifin (eFT226) in Subjects with Selected Advanced Solid Tumor Malignancies

Mechanism of Action:  eFT226 is a potent and selective inhibitor of translation of select mRNAs

Target Population:  .  ER positive breast cancer with FGFR amplifications, and NSCLC with KRAS G12C mutations (in combination with Sotorasib)

Study Design:  In Dose Escalation Study drug is administered IV weekly.

• GENMAB (GCT1046-04)
  • A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor
  • PI: Dr. Chen
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

A Phase III Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterized by PTEN deficiency (CAPItello-281)

Principal Investigator: Dr. Eric Batts

For more information on this trial, read its profile on clinicaltrials.gov here.

• • A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination with Durvalumab and Chemotherapy in Participants with Locally Advanced or Metastatic Solid Tumours
  • PI: Dr. Chandana
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

For more information on this trial, read its profile on clinicaltrials.gov

• • A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9)
  • PI: Dr. Chen
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Principal Investigator: Dr. Manish Sharma

For more information on this trial, read its profile on clinicaltrials.gov here.

Description:   A Phase I-II, First –in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies

Mechanism of Action: Antibody drug conjugate to TROP-2.  This drug is very similar to Sacituzumab which has FDA approval in TNBC. 

Target Patient Population: .  Currently only open for gastric cancer. 

Study Design:   Drug is given IV every 2 weeks

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

Principal Investigator: Dr. Sreenivasa Chandana

For more information on this trial, read its profile on clinicaltrials.gov here.

• GENMAB (GCT1046-04)
  • A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor
  • PI: Dr. Chen
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in adult patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Principal Investigator: Dr. Yuanbin Chen

For more information on this trial, read its profile on clinicaltrials.gov here.

Description:  A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination with Pembrolizumab in Patients with Advanced Cancers

Mechanism of Action:  cleaves off immunosuppressive sialoglycans from immune and tumor cells to enhance antitumor immunity

Target Patient Population:   Melanoma, Ovarian, Non Small Cell Lung Cancer, Colorectal and Pancreatic cancers

Study Design:  Drug is given IV weekly.

Description:  Phase 1/2a Dose Escalation, Finding and Expansion Study Evaluating Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of PF-07104091 as a Single Agent and in Combination Therapy.

Mechanism of Action:  CDK2 inhibitor

Target Patient Population:   Small cell Lung Cancer, Platinum Resistant Ovarian, Non-small cell Lung Cancer; in combination with palbociclib and fulvestrant for HR+ HER2- Metastatic Breast Cancer (3^rd line plus)

Study Design:  Drug is given orally twice daily.

Description:  A Phase 1/1B Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of PF-07220060 as a Single Agent and As Part of Combination Therapy In Participants With Advanced Solid Tumors.

Mechanism of Action:  CDK4 inhibitor

Target Patient Population:   Metastatic Breast Cancer, NSCLC (adeno), Prostate cancer, Colorectal cancer, Liposarcoma and tumor types with CDK4 or CCND1 amplification; in combination with letrozole/fulvestrant for HR+ HER2- breast cancer

Study Design:  Drug is given orally twice daily

Description:  A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors

Mechanism of Action:  .antibody drug conjugate to B7H4V.  B7H4 is an immune checkpoint protein present on cancer cells

Target Patient Population:  Ovarian, Primary peritoneal or Fallopian, Breast (HER2-, HR+), Triple Negative Breast, Endometrial, Squamous Non Small Cell Lung, Cholangiocarcinoma, Gallbladder cancers.

Study Design:  Drug is administered IV 21 day cycle (Day 1, 8 or Day 1 only)

A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

Principal Investigator: Dr. Brett Brinker

For more information on this trial, read its profile on clinicaltrials.gov here.

Description: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤65 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma

Principal Investigator: Dr. Brett Brinker

For more information on this trial, read its profile on clinicaltrials.gov here.

A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Principal Investigator: Dr. Erin Pettijohn

For more information on this trial, read its profile on clinicaltrials.gov here.

• • A Randomized, Open-label Phase 3 Study of Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myeloma (COBRA)
  • PI: Dr. Brinker
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry

Primary Investigator: Dr. Erin Pettijohn

For more information on this trial, read its profile on clinicaltrials.gov here.

A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Principal Investigator: Dr. Erin Pettijohn

For more information on this trial, read its profile on clinicaltrials.gov here.

ALKS 4230-003 (Alkermes Inc. )

Description:  Clinical and Immunologic Activity of Nemvaleukin Alfa With a less Frequent IV Dosing With Pembrolizumab and Impact on Tumor Microenvironment in Soloid Tumor Patients (Artistry-3)

Mechanism of Action:  IL2 receptor agonist

Target Patient Population: Cutaneous melanoma, Renal Cell, Triple Negative Breast, MMS Colorectal, Ovarian and any MSI-High solid tumors

Study Design: Study drug is administered IV every 3 weeks

AT148002 (ALX Oncology)

 Description:   A Phase 1/2 Study of ALX148 in Combination with Azacitidine in Patients with Higher Risk Myelodysplastic Syndrome (MDS)

Mechanism of Action:  ALX148 is a CD47 blocker.

Target Patient Population: High Risk MDS

Study Design:  Study Drug will be administered IV every 2 or 4 weeks.  Combination drug, Azacitidine given as would Standard of Care.

ALPN-202 – NEON-1 (Alpine Immune Sciences)

Description:  An open-Label Study of ALPN-202 In Subjects With Advanced Malignancies (NEON-1)

 Mechanism of Action: Inhibits PDL1 and CTLA4, engages CD28 co-stimulator.

Target Patient Population: Currently in expansion for Melanoma, Renal cell  and PDL1 positive cancers only

Study Design: Study drug is administered IV every 1 or 3 weeks

A Phase III Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterized by PTEN deficiency (CAPItello-281)

Principal Investigator: Dr. Eric Batts

For more information on this trial, read its profile on clinicaltrials.gov here.

• • A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination with Durvalumab and Chemotherapy in Participants with Locally Advanced or Metastatic Solid Tumours
  • PI: Dr. Chandana
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion

For more information on this trial, read its profile on clinicaltrials.gov

• • A Phase III, double-blind, placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9)
  • PI: Dr. Chen
  • Available at: CHCWM – Muskegon, Holland Cancer Center, Lacks Cancer Center at Saint Mary’s, Lemmen-Holton Cancer Pavilion