SG2501 for Blood Cancers and Lymphoma

No longer recruiting at 7 trial locations

Overseen By Nashat Gabrail, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

Must not be taking: Anticancer, Corticosteroids, Antiviral, others

Disqualifiers: CNS metastases, Cardiac disease, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SG2501 for individuals with certain blood cancers and types of lymphoma that have not responded to other treatments. The main goal is to determine the treatment's safety and its effects on the body. This trial suits adults who have tried other therapies without success and have cancers like multiple myeloma or lymphoma that persist or resist current treatments. Participants will receive SG2501 through intravenous (IV) infusions to help researchers assess its effectiveness and safety. As a Phase 1 trial, this research focuses on understanding how SG2501 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that anticancer therapy should be stopped within 5 half-lives or 4 weeks before the study, and certain medications like hydroxyurea may be used during the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SG2501 is likely to be safe for humans?

Research has shown that SG2501 was tested in a study with 24 patients who had difficult-to-treat forms of Hodgkin lymphoma or a specific type of non-Hodgkin lymphoma. In this study, SG2501 proved to be safe, with patients mostly experiencing mild side effects. This suggests that SG2501 might be well-tolerated, but it is important to remember that this is still early research. The current trial is in its first phase, testing SG2501 in humans for the first time to assess its safety and how people respond to it. This phase is crucial for ensuring the treatment's safety before moving on to larger studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SG2501 is unique because it offers a novel approach to treating blood cancers and lymphoma by using a specific intravenous (IV) infusion method. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, SG2501 is designed to act more specifically, potentially minimizing damage to healthy cells and reducing side effects. Researchers are excited about SG2501 because its targeted mechanism of action could lead to more effective treatments with fewer adverse effects, improving the quality of life for patients.

What evidence suggests that SG2501 might be an effective treatment for blood cancers and lymphoma?

Research has shown that SG2501 blocks a pathway cancer cells use to survive, allowing them to evade the immune system. In studies of similar treatments, many patients with certain blood cancers responded well, with up to 91% showing improvement. Specifically, 56% of patients experienced complete remission, meaning their cancer symptoms disappeared. These early findings suggest that SG2501, administered as monotherapy in this trial, could be a promising option for individuals with relapsed or difficult-to-treat blood cancers and lymphoma. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults with certain blood cancers or lymphoma that haven't responded to previous treatments can join this trial. They must be willing to use contraception and have a life expectancy of at least 12 weeks. Key organ functions need to be adequate, and they should not have had major surgery recently or any other serious medical conditions that could interfere with the study.

Inclusion Criteria

Baseline Left Ventricular Ejection Fraction (LVEF) ≥ 50%

My liver is functioning well.

Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures

Exclusion Criteria

I have active tuberculosis.

I have not had major surgery in the last 4 weeks.

I have active hepatitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase Ia

Phase Ia consists of an accelerated titration using single patient cohorts to evaluate SG2501 at lower dose levels, followed by dose-escalation using multipatient cohorts to establish a maximum tolerated dose (MTD).

24 weeks

Weekly doses

Treatment Phase Ib

Phase Ib consists of dose expansion cohorts with SG2501 monotherapy in subjects with relapsed or refractory multiple myeloma (MM) or diffuse large B-cell lymphoma (DLBCL).

24 weeks

Weekly doses

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SG2501

Trial Overview SG2501 is being tested in adults with relapsed or refractory hematological malignancies and lymphoma. This early-phase trial will gradually increase doses to find safe levels, understand how the body processes the drug, check for preliminary signs of effectiveness, and explore potential biomarkers.

How Is the Trial Designed?

Group I: SG2501 Experimental Treatment 1 Intervention

SG2501 monotherapy intravenous (IV) infusion - Weekly doses

Who Is Running the Clinical Trial?

Hangzhou Sumgen Biotech Co., Ltd.

Lead Sponsor

Trials

7

Recruited

770+

Published Research Related to This Trial

In a phase 1 study involving 16 patients with relapsed/refractory lymphoma, SAR245409 (voxtalisib) demonstrated preliminary efficacy with one complete response and two partial responses, indicating its potential effectiveness in treating this type of cancer.

The treatment was generally well-tolerated, with common side effects including nausea (31.3%) and diarrhea (25.0%), and showed significant inhibition of key cancer pathways, suggesting a mechanism of action that could be beneficial for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, pharmacokinetics and pharmacodynamics of SAR245409 (voxtalisib, XL765), an orally administered phosphoinositide 3-kinase/mammalian target of rapamycin inhibitor: a phase 1 expansion cohort in patients with relapsed or refractory lymphoma. Papadopoulos, KP., Egile, C., Ruiz-Soto, R., et al.[2021]

A study analyzing 2069 reports of sacituzumab govitecan (SG) from the FDA Adverse Event Reporting System found that SG is significantly associated with increased risks of blood lymphatic system disorders and hepatobiliary disorders, indicating important safety concerns for patients.

In addition to common adverse events like anemia and neutropenia, the study identified unexpected significant adverse events such as colitis and meningitis, highlighting the need for ongoing monitoring and safety management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing safety surveillance of sacituzumab govitecan: an observational, pharmacovigilance study leveraging FAERS database. Liu, W., Du, Q., Guo, Z., et al.[2023]

In a study of 502 patients with newly diagnosed follicular lymphoma, higher pretreatment levels of serum soluble interleukin-2 receptor (sIL-2R) were linked to worse overall survival, disease-specific survival, and progression-free survival outcomes.

The research demonstrated a clear dose-dependent relationship, indicating that as serum sIL-2R levels increased, the probability of survival decreased, suggesting that sIL-2R could be a valuable prognostic marker for treatment outcomes in follicular lymphoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment serum soluble interleukin-2 receptor level predicts survival in patients with newly diagnosed follicular lymphoma. Nozaki, K., Sugahara, H., Ueda, S., et al.[2022]

SGN-30, a monoclonal antibody targeting CD30+ cancers, shows promise in treating Hodgkin's disease and anaplastic large cell lymphoma by activating growth-regulating pathways and inducing cell growth arrest.

In combination with standard chemotherapy agents, SGN-30 enhances their effectiveness, suggesting it could improve treatment outcomes for patients with CD30+ malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signaling via the anti-CD30 mAb SGN-30 sensitizes Hodgkin's disease cells to conventional chemotherapeutics. Cerveny, CG., Law, CL., McCormick, RS., et al.[2019]

SGN-CD19B is a promising anti-CD19 antibody drug conjugate that shows improved potency in treating relapsed/refractory B-cell malignancies, inducing cell death through a unique mechanism that causes DNA damage rather than using traditional microtubule inhibitors.

In preclinical studies, SGN-CD19B demonstrated effective and durable tumor regressions at lower doses compared to other antibody drug conjugates, and it was well-tolerated in cynomolgus monkeys, indicating its potential for safe clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Ryan, MC., Palanca-Wessels, MC., Schimpf, B., et al.[2021]

In a first-in-human study involving 20 patients with relapsed or refractory CD70-positive non-Hodgkin lymphoma, SGN-CD70A demonstrated modest antitumor activity, achieving 1 complete remission and 3 partial remissions, with some responses lasting over 42 weeks.

However, the treatment was associated with significant adverse effects, particularly thrombocytopenia occurring in 75% of patients, which limited the frequency of dosing and raised safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 trial of SGN-CD70A in patients with CD70-positive diffuse large B cell lymphoma and mantle cell lymphoma. Phillips, T., Barr, PM., Park, SI., et al.[2020]

SGN-35, an antibody-drug conjugate targeting CD30, effectively releases the potent drug MMAE inside CD30(+) cancer cells, achieving high intracellular concentrations that contribute to its therapeutic effects.

MMAE not only kills CD30(+) cells but can also diffuse to and exert cytotoxic effects on neighboring CD30(-) cells, enhancing the overall antitumor activity of SGN-35 in mixed tumor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Okeley, NM., Miyamoto, JB., Zhang, X., et al.[2021]

In a Phase 1 study involving 24 patients with refractory Hodgkin lymphoma or CD30(+) non-Hodgkin lymphoma, SGN-30 was found to be safe with mild adverse effects, and the maximum tolerated dose was not reached.

The treatment showed modest clinical activity, with one patient achieving a complete response and six others maintaining stable disease for 6 to 16 months, indicating potential effectiveness in targeting CD30(+) malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Bartlett, NL., Younes, A., Carabasi, MH., et al.[2021]

In a study of 338 patients with chronic lymphocytic leukemia (CLL), those with serum soluble CD23 (sCD23) levels greater than 1000 UI/L exhibited worse clinical outcomes, including a higher likelihood of requiring treatment sooner and lower overall survival rates.

High sCD23 levels were found to be a significant predictor of shorter treatment-free survival and may provide insights into the mechanisms of treatment response and resistance in CLL patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum soluble CD23 levels are an independent predictor of time to first treatment in chronic lymphocytic leukemia. Piñeyroa, JA., Magnano, L., Rivero, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05293912

SG2501 Safety Study in Subjects with Relapsed or ... This is a phase Ia/Ib, first-in-Human, open-Label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, ...

2. bereflected.org bereflected.org/clinical-trials/listings/338131/sg2501-safety-study-in/

Study on SG2501 safety for blood cancer and lymphoma ... This study is for people with certain blood cancers that have come back or not responded to treatment. It's called a Phase Ia/Ib study, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10425755/

Targeting CD47-SIRPα axis for Hodgkin and non- ... These antibodies exert efficacy through several mechanisms, including (i) inducing apoptosis or suppressing proliferation of lymphoma cells; (ii) suppressing ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0006647

Lymphoma (DBCOND0006647) SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma. SG2501 ... Analysis of Data Collected in the European Group ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211383522005251

Building on the backbone of CD47-based therapy in cancer The phase Ib results demonstrated that the objective response rate (ORR) of patients with MDS was 91% (30/33), and its complete remission (CR) rate reached 56% ...

6. withpower.com withpower.com/trial/phase-1-neoplasms-3-2022-b8f0b

SG2501 for Blood Cancers and Lymphoma In a Phase 1 study involving 24 patients with refractory Hodgkin lymphoma or CD30(+) non-Hodgkin lymphoma, SGN-30 was found to be safe with mild adverse effects ...