AT-1965 for Cancer

Recruiting at 6 trial locations

Overseen By Eldho Jose

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alyssum Therapeutics

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Uncontrolled diabetes, Autoimmune disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AT-1965, to assess its safety and effectiveness in treating advanced solid tumors that cannot be surgically removed or have metastasized. Researchers aim to determine the right dose, monitor for side effects, and evaluate the drug's potential to shrink tumors. Individuals with solid tumors unresponsive to standard treatments may be suitable for this trial, including those with conditions like triple-negative breast cancer who have not found success with other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that AT-1965 is likely to be safe for humans?

Research has shown that AT-1965 has a promising safety record in earlier studies. Tests on different animals demonstrated that the drug is absorbed and removed from the body efficiently. While information from human trials is still being gathered, these results suggest that AT-1965 might also be safe for people.

Since this trial is in its early stages, the main goal is to determine the safe dosage for humans. Researchers are closely monitoring for any side effects. Although the safety of AT-1965 in humans is still under investigation, early studies provide a positive outlook. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments, which typically involve chemotherapy, radiation, or traditional surgery, AT-1965 is unique because it uses a targeted liposome injection to deliver the drug directly to cancer cells. This method minimizes damage to healthy cells, potentially reducing side effects compared to conventional therapies. Researchers are excited about AT-1965 because its novel delivery system might improve treatment efficacy and patient quality of life.

What evidence suggests that AT-1965 might be an effective treatment for cancer?

Research has shown that treatments like AT-1965, administered in this trial as a liposome injection, hold promise for cancer therapy. Liposomes, tiny bubbles that deliver medicine directly to cancer cells, enhance treatment effectiveness and reduce side effects. Studies have found that liposomes help the medicine remain in the body longer and target cancer cells more precisely. Early results suggest that using liposomes can improve the efficacy of anticancer drugs and may lead to better outcomes for patients with difficult-to-treat cancers. Although AT-1965 is still under investigation, the technology behind it has proven beneficial in other cancer treatments. ^{1 6 7 8 9}

Who Is on the Research Team?

Richard Fahrner, PhD

Principal Investigator

Alyssum Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that are not removable by surgery or have spread, and which haven't responded to standard treatments. Participants must have recovered from previous treatment side effects (except hair loss) and should be relatively fit (ECOG status of 0 or 1). They need at least one tumor that can be measured on scans, adequate blood counts, kidney function, and liver enzymes within certain limits.

Inclusion Criteria

My kidney, liver, and bone marrow are functioning well.

It has been at least 28 days since my last COVID-19 mRNA vaccine shot.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

My hormone levels are stable with my current treatment.

Patients with a history of autoimmune disease. Excluded autoimmune conditions are listed in the Protocol Appendix 1

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Phase

Participants receive escalating doses of AT-1965 to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).

28 days per cycle

Visits on Days 1, 8, and 15 of each cycle

Dose Expansion Phase

Participants receive the recommended Phase 2 dose to further evaluate safety and preliminary antitumor activity.

28 days per cycle

Visits on Days 1, 8, and 15 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AT-1965

Trial Overview The study tests AT-1965 Liposome Injection in patients with tough-to-treat solid tumors. It's a Phase 1/2 trial aiming to find the highest dose patients can take without serious side effects (MTD), decide on a recommended dose for future studies (RP2D), understand how the drug behaves in the body (PK/PD), and see if it shrinks tumors.

How Is the Trial Designed?

Group I: AT-1965 Liposome Injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Alyssum Therapeutics

Lead Sponsor

Trials

1

Recruited

90+

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Published Research Related to This Trial

Survival rates for lymphoma and leukemia patients significantly improved from 1950 to 1973, with the most notable increase seen in acute lymphocytic leukemia, while chronic granulocytic leukemia showed the least improvement.

Cancer mortality rates decreased by 20% for individuals up to 45 years old, but there was an 8% increase in mortality for those over 55, highlighting a complex trend in cancer outcomes across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of cancer therapy on survival. Stonehill, EH.[2019]

Cancer incidence rates are significantly higher in individuals aged 65 and older, with rates for older males being four times and for older females being twice that of younger age groups (45 to 64 years).

Despite higher incidence rates, the relative survival rates for older patients (65+) are only slightly lower than those for younger patients (45 to 64), indicating that older patients generally have similar outcomes once diagnosed, except for certain cancers like urinary bladder and non-Hodgkin's lymphomas where survival rates are notably lower.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer incidence and survival in patients 65 years of age and older. Baranovsky, A., Myers, MH.[2019]

Cancers diagnosed in Saskatchewan between 1967 and 1986 showed high 15-year relative survival rates for certain types, such as lip cancer and melanoma in women, indicating effective treatment outcomes for these cancers.

Survival rates improved for cases diagnosed between 1980-1984 compared to those from 1970-1974 across various cancer types, with stage at diagnosis being a crucial factor for colorectal cancer survival, more so than age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival rates among patients with cancer in Saskatchewan, 1967-1986. Mao, Y., Robson, D., Semenciw, RM., et al.[2018]

In a study of 57,068 women diagnosed with breast cancer in Sweden from 1960 to 1978, those aged 45 to 49 had the best relative survival rates, outperforming younger patients by up to 12.9% over time.

Relative survival rates significantly declined for women over 49, especially for those over 75, indicating that older age is associated with worse long-term outcomes in breast cancer, with mortality rates exceeding 5% in the oldest age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between survival and age at diagnosis in breast cancer. Adami, HO., Malker, B., Holmberg, L., et al.[2022]

Cancer incidence in adolescents and young adults (ages 15-30) is 2.7 times higher than in younger children, but still accounts for only 2% of all invasive cancers, with specific types like Hodgkin lymphoma and melanoma being most common.

Survival rates for young adults diagnosed with cancer have not improved over the past 25 years, with males and certain racial groups, such as African Americans, experiencing worse prognoses compared to non-Hispanic whites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer in 15- to 29-year-olds by primary site. Bleyer, A., Viny, A., Barr, R.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10095497/

Liposomes in Cancer Therapy: How Did We Start and Where ... Liposomes have several advantages, including improved pharmacokinetic properties of the encapsulated drug, reduced systemic toxicity, extended ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06234098

NCT06234098 | Study to Investigate the Safety, Tolerability ... AT-1965 Liposome Injection administered intravenously once weekly for the first 3 weeks (Days 1, 8 and 15) of a 4 week cycle. What is the study measuring?

3. sciencedirect.com sciencedirect.com/science/article/pii/S0928098723003160

Recent advances and clinical translation of liposomal ... Research in liposomal nanomedicine for cancer therapy is rapidly increasing, opening up new horizons for cancer treatment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10974372/

Liposome-Based Drug Delivery Systems in Cancer Research Liposomes were employed as drug delivery systems so as to selectively target cancer cells and improve the bioavailability of anticancer drugs.

5. scielo.br scielo.br/j/babt/a/P8DqhfXHQgcVQmwcpY8CgXK/

Liposome and Their Applications in Cancer Therapy This review summarizes the types of methods used for the preparation of liposomes, mechanism of drug loading and potential therapeutic applications in cancer ...

6. cancertrials.ohsu.edu cancertrials.ohsu.edu/s/a-phase-12-study-of-at-1965-in-patients-with-advanced-refractory-or-recurrent-solid-tumor-208446/

A Phase 1/2 study of AT-1965 in Patients with Advanced, ... We are hoping to determine how much AT-1965 can be safety be administered to people with advanced cancer, the potential side effects of the study drug and how ...

7. aacrjournals.org aacrjournals.org/cancerres/article/78/13_Supplement/4918/629419/Abstract-4918-Pharmacokinetics-and-toxicity

Pharmacokinetics and toxicity studies of AT1965, a B-cell ... Conclusion: The excellent pharmacokinetic profile of AT1965 showing high exposure and enhanced elimination half-life tested across species, in ...

8. withpower.com withpower.com/trial/phase-2-tumors-solid-1-2024-a7fa8

AT-1965 for Cancer · Recruiting Participants for Phase ... The drug AT-1965 is considered promising for cancer treatment because it offers hope for improving survival rates, especially in older patients who generally ...

9. researchgate.net researchgate.net/publication/327087696_Abstract_4918_Pharmacokinetics_and_toxicity_studies_of_AT1965_a_B-cell_activating_immunotherapy

Pharmacokinetics and toxicity studies of AT1965, a B-cell ... In this study, we have evaluated the metabolism, pharmacokinetics (PK) and toxicity of AT1965 in rodent and non-rodent species. Methods: AT1965 ...