What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy often causes nausea, vomiting, hair loss, fatigue, and myelosuppression, leading to increased infection risk. Targeted therapies can result in skin rashes, diarrhea, liver toxicity, and hypertension. Immunotherapy, including PD-1 and CTLA-4 inhibitors, may cause immune-related adverse events like colitis, pneumonitis, hepatitis, and endocrinopathies. These side effects vary in severity and frequency depending on the specific drugs and patient factors.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, particularly focusing on immune checkpoint inhibitors and targeted therapies. Pembrolizumab and nivolumab, both PD-1 inhibitors, have been approved for various solid tumors including melanoma, non-small cell lung cancer, and renal cell carcinoma. Additionally, ipilimumab, a CTLA-4 inhibitor, is approved for melanoma. Targeted therapies such as bevacizumab, an anti-VEGF antibody, and trastuzumab, an anti-HER2 antibody, are also widely used in solid tumors like colorectal cancer and breast cancer, respectively. These approvals highlight the trend towards utilizing the body's immune system and specific molecular targets to combat cancer.

What other types of research exist?

Promising novel alternatives for solid tumor patients in 2024 include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, as seen in the KEYNOTE-189 trial for non-small-cell lung cancer. 2) Atezolizumab (Tecentriq) combined with bevacizumab and chemotherapy, as demonstrated in the IMpower150 trial for non-small-cell lung cancer. 3) Nivolumab (Opdivo) plus ipilimumab (Yervoy), which has shown efficacy in various solid tumors including renal cell carcinoma and mesothelioma. 4) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer, as evidenced by the VISION trial.

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Monoclonal Antibodies

AMG 305 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Amgen

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 up to a maximum of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AMG 305 in adults to see if it is safe and how well people can tolerate it. Researchers will start with a low dose and gradually increase it to find the best amount that works without causing too many side effects.

Who is the study for?

Adults over 18 with certain solid tumors (like colorectal, lung, pancreatic cancers) who've tried all standard treatments or can't have them. They must be relatively healthy (ECOG 0-1), have a life expectancy over 3 months, and not be pregnant or breastfeeding. Excluded are those with active infections, lung disease, hepatitis B/C, HIV, autoimmune disorders needing steroids/immunosuppressants, recent major surgery or vaccine; also if they're on other trials.

What is being tested?

The trial is testing AMG 305's safety and what dose works best without being too much for people with advanced solid tumors. It aims to find the highest dose patients can take without serious side effects (MTD) and decide the right amount for future studies (RP2D).

What are the potential side effects?

While specific side effects of AMG 305 aren't listed here, common ones in cancer drug trials include nausea, fatigue, risk of infection due to immune system impact; organ inflammation; allergic reactions; blood clots or bleeding issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to a maximum of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to a maximum of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a maximum of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)

Secondary study objectives

Duration of Response (DOR)

ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Dose ExpansionExperimental Treatment1 Intervention

Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and other solid tumors will receive the RP2D identified in Part A.

Group II: Part A: Dose ExplorationExperimental Treatment1 Intervention

Participants will receive escalating doses of AMG 305.

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

The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapy aims at specific molecules involved in cancer growth and survival, such as tyrosine kinases or hormone receptors, offering a more precise approach with potentially fewer side effects. Immunotherapy leverages the body's immune system to recognize and destroy cancer cells, often by inhibiting checkpoints that prevent immune activation. These mechanisms are crucial for solid tumor patients as they provide multiple avenues to attack the cancer, potentially improving outcomes and offering options when tumors become resistant to one type of treatment. Treatments like AMG 305, though not specified, likely fall into one of these categories, aiming to enhance efficacy and reduce toxicity in managing advanced solid tumors.