What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often result in side effects such as neutropenia, anemia, thrombocytopenia, nausea, vomiting, diarrhea, constipation, fatigue, hypertension, and skin reactions. Specific agents like gemcitabine and pemetrexed can cause significant hematologic toxicities, while immunotherapies like durvalumab may lead to pneumonitis, rash, and pruritus.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors include enasidenib for relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation, gemtuzumab ozogamicin for AML with CD33-expressing leukemic blasts, and pembrolizumab for advanced or metastatic melanoma. Additionally, treatments like pazopanib for soft tissue sarcoma and lutetium Lu 177 vipivotide tetraxetan for PSMA-positive metastatic castration-resistant prostate cancer (CRPC) have shown efficacy. These treatments, while varied in their mechanisms, represent the broad spectrum of FDA-approved therapies for advanced solid tumors.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: <ol> <li>Pembrolizumab (Keytruda) - an immune checkpoint inhibitor used in combination with chemotherapy for various solid tumors, including non-small cell lung cancer (NSCLC) and gastric cancer.</li> <li></li> </ol> Nivolumab (Opdivo) - another immune checkpoint inhibitor, often used in combination with other therapies for cancers such as melanoma, esophageal cancer, and NSCLC. 3. Anamorelin - a ghrelin mimetic showing promise in managing cancer cachexia, particularly in NSCLC patients. 4. Infigratinib (TRUSELTIQ) - an FGFR-selective tyrosine kinase inhibitor for cholangiocarcinoma with FGFR2 gene fusions or rearrangements. 5. Futibatinib - another FGFR inhibitor recently approved for cholangiocarcinoma. These therapies represent significant advancements in the treatment of solid tumors and offer new hope for patients.

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Other

GI-102 for Advanced Cancer

Phase 1 & 2

Recruiting

Research Sponsored by GI Innovation, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month, 12-month, and 18-month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing GI-102, a new protein treatment, in patients with advanced or spreading tumors. The treatment aims to help the immune system fight cancer by boosting certain immune cells while avoiding those that suppress the response.

Who is the study for?

Adults with advanced solid tumors who have good organ and bone marrow function, measurable disease, a performance status indicating they can care for themselves (ECOG 0-1), and no severe recent side effects from past cancer treatments. HIV+ patients must be on effective ART. Not eligible if they have active brain metastases, another cancer, hepatitis B or C infections, tuberculosis, uncontrolled infections, recent immunotherapies like GI-102's action mode or any cancer treatment within the last month.

What is being tested?

The trial is testing GI-102 as a single agent to see how safe it is and how well it works against different types of advanced or spreading solid tumors. It will look at how the body processes the drug and its effectiveness in shrinking or controlling tumor growth.

What are the potential side effects?

Specific side effects of GI-102 are not listed but generally may include typical reactions such as fatigue, nausea, inflammation at injection sites, allergic reactions to components of the drug product/excipients of GI-102.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month, 12-month, and 18-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month, 12-month, and 18-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month, 12-month, and 18-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and nature of Dose-Limiting Toxicity (DLTs) (dose escalation phase of Part A and B)

Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs) (dose escalation phase of Part A and B)

Objective Response Rate (ORR) (dose optimization phase of Part A, dose expansion phase of Part B, Part C and D)

Secondary study objectives

Area under the plasma concentration versus time curve (AUC) of GI-102

Clearance of GI-102

Disease Control Rate (DCR)

+9 more

Other study objectives

Immunophenotyping of peripheral blood CD4+ T cells

Immunophenotyping of peripheral blood CD8+ T cells

Immunophenotyping of peripheral blood Treg cells

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: GI-102 subcutaneous (SC)Experimental Treatment1 Intervention

Dose escalation: GI-102 subcutaneous (SC), multiple ascending doses Dose expansion: GI-102 subcutaneous (SC), sRP2D

Group II: GI-102 + trastuzumab deruxtecan (T-DXd)Experimental Treatment2 Interventions

Group III: GI-102 + pembrolizumabExperimental Treatment2 Interventions

Group IV: GI-102 + paclitaxel + bevacizumabExperimental Treatment3 Interventions

Group V: GI-102 + eribulinExperimental Treatment2 Interventions

Group VI: GI-102 + doxorubicinExperimental Treatment2 Interventions

Group VII: GI-102Experimental Treatment1 Intervention

Dose escalation: GI-102 intravenous (IV), multiple ascending doses Dose optimization: GI-102 intravenous (IV), sRP2D Dose optimization: GI-102 intravenous (IV), sRP2D-1 (or sRP2D+1)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

eribulin

2009

Completed Phase 3

~630

pembrolizumab

2017

Completed Phase 3

~5890

bevacizumab

2002

Completed Phase 3

~3360

doxorubicin

2005

Completed Phase 3

~9130

paclitaxel

1996

Completed Phase 3

~4310

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Radiation therapy uses high-energy particles to damage the DNA of cancer cells, leading to cell death. These mechanisms are crucial for solid tumor patients as they offer multiple approaches to control and potentially eradicate tumors, improving survival and quality of life.

Current trends and future directions in the genetic therapy of human neoplastic disease.