West Cancer Center

BLADDER: METASTATIC: PHASE 1: ASPEN-07

A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)

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Malignancy

Bladder cancer, urothelial carcinoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Investigational Agent

Evorpacept

Drug Class

Fusion protein blocking CD47-SIRPalpha

PI

Dan Vaena, MD

Sponsor

ALX Oncology

Path

Urothelial carcinoma

Key Eligibility Criteria Details

Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma. Subjects with urothelial carcinoma with squamous differentiation or mixed cell types are eligible provided that urothelial is the dominant histology. Any element of neuroendocrine or small cell histology are excluded
Must have received prior treatment with a immune checkpoint inhibitor in the locally advanced or metastatic setting
Must have received prior treatment with platinum containing chemotherapy defined as received in the adjuvant/neoadjuvant setting with recurrent or progressive disease within 12 months of completion OR received treatment with platinum in the locally advanced or metastatic setting
Must have had progression or recurrence during or following recept of most recent therapy
ECOG PS 0-1
Dose escalation cohorts must have available archival or fresh biopsy sample prior to study entry. Others must have tumor accfessible for sequential biopsy and be willing to provide fresh pre-treatment and on-study tumor tissue biopsies
No pre-existing sensory or motor neuropathy Grade >/= 2
No symptomatic or unctrolled CNS metastases
No prior treatment with enfortumab vedotin
No prior treatment with any anti-CD47 or anti-SIRPa agent
No known uncontrolled HBV/HCV/HIV
No other malignancy within 3 years
No active autoimmune disease requiring treatment in last year

SUPPORTIVE CARE: DIARRHEA PROPHYLAXIS: ON TARGETED THERAPY: ON-TARGET

ON TARGET: A Phase 3 multicenter, randomized, double-blind placebo-controlled trial evaluating crofelemer for the prophylaxis of diarrhea in adult patients with solid tumors
receiving targeted-cancer therapies with or without standard chemotherapy regimens

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Malignancy

Breast, Lung, Bladder, Gastric, Esophageal, Kidney, Renal, RCC, NSCLC, Melanoma, thyroid, sarcoma, liver, HCC, GIST, PNET,

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

Any

Investigational Agent

Crofelemer

Drug Class

Botanical oligomeric proanthocyanidin

PI

Lee Schwartzberg, MD

Sponsor

Napo Pharmaceuticals

Path

Any

Key Eligibility Criteria Details

Patient planned to receive one of the following agents for Cancer with or without chemotherapy that has a risk of diarrhea in 50% of patients
- CDK4/6 inhibitors (abemaciclib),
- PI3 kinase blockers (alpelisib),
- anti-EGFR TKIs (afatinib, dacomitinib, erlotinib, gefitinib)
- anti VEGF-TKIs (axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib, sunitinib, vendatinib)
- anti ALK TKIs (ceritinib, crizotinib)
- MEK inhibitor (cobimetinib)
- Anti HER2 TKIs (lapatinib, tucatinib)
ECOG PS 0-2
Not receiving immunotherapy (PD-1, CTLA-4, IL-2)
No diarrhea before enrolling on the study (or starting TKI)
No ongoing IBS or colitis
Not planning on receiving an agent where anti-diarrheal prophylaxis is mandatory (e.g. neratinib, irinotecan, etc.)
No laxative use within 7 days prior to randomization

ADVANCED SOLID TUMORS: RCC, Breast, Prostate, Bladder, CRC: STELLAR-001

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

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Malignancy

Renal cell carcinoma, hormone receptor positive breast cancer, castration-resistant prostate cancer, urothelial cancer, colorectal cancer (HR+ BC, RCC, CRPC, Bladder, CRC)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Generally at least 1 prior line. Some exceptions

Investigational Agent

XL092

Drug Class

VEGF/MET kinase inhibitor

PI

Dan Vaena, MD

Sponsor

Exelixis

Path

Key Eligibility Criteria Details

Expansion Cohort A (ccRCC): Subjects with previously treated advanced RCC with clear cell histology (including those with a sarcomatoid component) who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
Expansion Cohorts B and E (nccRCC): Subjects with previously treated advanced RCC with non-clear cell histology who have radiographically progressed following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
Expansion Cohorts C and F (HR+ BC): Subjects with breast cancer that is hormone receptor positive (ER+ and/or PR+) and negative for human epidermal growth factor receptor 2 (HER-2) and who have radiographically progressed during or following treatment with at least one prior systemic anticancer regimen for inoperable locally advanced or metastatic disease.
Expansion Cohorts D and G (mCRPC): Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
Expansion Cohort H (CRC): Subjects with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum who received prior fluoropyrimidine-containing chemotherapy with oxaliplatin and irinotecan.
- KRAS/NRAS wild type
- Must have received all of the following: fluropyridmidine, irinotecan, oxaliplatin, EGFR monoclonal antibody, and, for those with BRAF mutation, BRAF inhibitor in combination with cetuximab
- Must have progression during or within 3 months following the last dose of the most recent regimen
- Prior therapy with regorafenib or TAS-102 are NOT allowed
Expansion Cohort I (UC, Maintenance Therapy): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who received first-line chemotherapy of gemcitabine + cisplatin and/or gemcitabine + carboplatin.
Expansion Cohort J (UC, ICI-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after PD-1/PD-L1 targeting ICI therapy.
Expansion Cohort K (UC, platinum-refractory): Subjects with histologically confirmed, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra) who progressed on or after first-line platinum-based combination therapy.
Locally advanced, recurrent, or metastatic
No known untreated CNS mets
ECOG PS 0-1

ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
Must have tumor specimen available
Measurable disease
ECOG PS 0-1
Life expectancy at least 12 weeks
Phase 1a- must have exhausted all standard therapies for their disease
Phase 1b- must have disease that has progressed after at least one available standard therapy
Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
No active HBV/HCV or chronic or acute EBV
No history of autoimmune disease
No symptomatic or actively progressing CNS mets

ADVANCED SOLID TUMORS: LATE LINE: GLOBO-H POSITIVE: OBI-999-001

A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients With Advanced Solid Tumors

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Malignancy

Pancreatic, Esophageal, Gastric, Colorectal, Breast, Lung, Prostate, Melanoma, Head and Neck, Sarcoma, Bladder, Renal Cell, Ovarian, Endometrial, Cervical

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-999

Drug Class

Globo H targeting agent

PI

Dan Vaena, MD

Sponsor

OBI Pharma

Path

Any solid tumor

Key Eligibility Criteria Details

Histologically or cytologicall confirmed patients with advanced solid tumors
Must have documented Globo H score of at least 100 from a qualified laboratory IHC assay
Must have been treated with established standard-f-care therapy or physicians have determined that such established therapy is not sufficiently efficacious or patients have declined to received standard-of-care therapy
ECOG PS 0-1
Measurable disease
Adequate organ function
No known untreated CNS mets
No significant clinical cardiac abnormality

ADVANCED SOLID TUMORS: CTL WT1 inducers: DSP7888-102CI

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

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Malignancy

Urothelial Neoplasm, Bladder Cancer, Renal Cell Carcinoma, Head and Neck, Lung Cancer, NSCLC, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Colorectal Cancer, Cervical Cancer, Melanoma

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

DSP-7888

Drug Class

peptide vaccine stimulating cytotoxic T-cells expressing WT1

PI

Dan Vaena, MD

Sponsor

Sumitomo Dainippon Pharma Oncology Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed metastatic cancer that is approved to be treated with nivolumab or pembrolizumab
Must not be eligible for curative resection
Must be positive for at least 1 of the following human leukocyte antigens:
- HLA-A*02:01
- HLA-A*02:06
- HLA-A*24:02
- HLA-A*03:01
- HLA-B*15:01
ECOG PS 0-1
No known CNS mets
No known HIV/HBV/HCV

METASTATIC SOLID TUMORS: PHASE 1 (ESCALATION): PVRIG+PD-1: CPG-01-001

A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.

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Malignancy

Ovarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

COM-701, PD(L)-1 antibody

Drug Class

PVRIG monoclonal antibody, PD(L)-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen

Path

Key Eligibility Criteria Details

Histologically or cytologically confirmed, metastatic solid malignancy
Has exhausted all available standard therapy or not a candidate for standard therapy
ECOG PS 0-1
Prior PD-1/PD-L1 allowed
No other malignancy within 2 years prior
No active autoimmune disease requiring systemic therapy within last 2 years
No chronic steroids or immunosuppressants.