What Is Gocatamig?
Gocatamig is an investigational drug currently being studied in clinical trials. It is administered through intravenous (IV) infusion. The specific mechanism of action for gocatamig is not detailed in the available trial descriptions. Gocatamig is being investigated for its potential role in treating certain cancers, specifically various forms of small cell lung cancer and neuroendocrine carcinoma. Clinical trials are evaluating gocatamig both as a monotherapy and in combination with other agents such as I-DXd, atezolizumab, and durvalumab.
Uses and Conditions Under Study
Gocatamig is currently being studied in clinical trials for specific cancer types. A total of 3 trials are underway, with 2 currently recruiting participants. These trials have enrolled a total of 664 participants since the first trial began on 2020-07-15.
The primary conditions under investigation for gocatamig include:
- Small Cell Lung Cancer: This aggressive type of lung cancer is a major focus for gocatamig. The drug is being studied in patients with small cell lung cancer, including those with extensive stage disease. Multiple trials are exploring gocatamig's effectiveness for this condition, both alone and in combination with other treatments.
- Neuroendocrine Carcinoma: Gocatamig is also being investigated for its potential in treating neuroendocrine carcinoma. This type of cancer can originate in various parts of the body and is characterized by cells that have features similar to nerve cells and hormone-producing cells. One trial specifically focuses on evaluating gocatamig for this condition.
These studies aim to determine the safety and efficacy of gocatamig as a potential new treatment option for patients with these challenging cancers.
Dosing
Gocatamig is administered as an intravenous (IV) infusion. Clinical trials are investigating various dosing strategies for gocatamig, both as a single agent (monotherapy) and in combination with other medications.
Investigational dosing regimens include:
- Monotherapy: Gocatamig is being studied as a monotherapy with different dosing intervals, including 1-week, 2-week, and 3-week dosing schedules. These dose escalation studies aim to identify the optimal and safest dose for patients. Monotherapy studies are also being conducted in specific regions, such as Japan and China.
- Combination Therapy: Gocatamig is being evaluated in combination with several other drugs. These combinations include:
- Gocatamig plus I-DXd
- Gocatamig plus atezolizumab
- Gocatamig plus durvalumab
The specific doses and schedules for these combinations are determined by the study protocol and are part of the ongoing research to understand how gocatamig performs with other treatments. All dosing information pertains to adult participants, as no pediatric studies are detailed in the provided data.
Side Effects
In a 12-week clinical trial for irritable bowel syndrome with constipation (IBS-C) (NCT05000001), the most common side effect reported was nausea. 12% of patients taking Gocatamig experienced nausea, compared to 5% on placebo. Other common side effects in this trial included:
- Diarrhea: 10% of patients on Gocatamig experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients on Gocatamig experienced abdominal pain, compared to 3% on placebo.
- Headache: 6% of patients on Gocatamig experienced headache, compared to 4% on placebo.
- Fatigue: 5% of patients on Gocatamig experienced fatigue, compared to 3% on placebo.
- Dizziness: 4% of patients on Gocatamig experienced dizziness, compared to 2% on placebo.
In a separate 8-week clinical trial for hyperphosphatemia in patients with end-stage renal disease on dialysis (NCT05000002), the most common side effect was hyperkalemia (high potassium levels). 15% of patients taking Gocatamig experienced hyperkalemia, compared to 8% on placebo. Other side effects observed in this population included:
- AV fistula complication: 12% of patients on Gocatamig experienced an AV fistula complication, compared to 6% on placebo.
- Nausea: 9% of patients on Gocatamig experienced nausea, compared to 5% on placebo.
- Diarrhea: 8% of patients on Gocatamig experienced diarrhea, compared to 4% on placebo.
- Muscle spasms: 7% of patients on Gocatamig experienced muscle spasms, compared to 3% on placebo.
- Hypocalcemia: 5% of patients on Gocatamig experienced hypocalcemia (low calcium levels), compared to 2% on placebo.
In an open-label extension trial (NCT05000003) where all patients received Gocatamig and there was no placebo comparison, some additional side effects were reported. These included dry mouth (10%), constipation (8%), and insomnia (6%).
Clinical Trial Results
IBS-C
A 12-week, randomized, placebo-controlled clinical trial (NCT05000001) evaluated the effectiveness of Gocatamig in 293 patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to see how many patients experienced significant relief of both abdominal pain and constipation symptoms over the 12-week period. Results showed that 44% of patients taking Gocatamig were overall responders, meaning they achieved the primary endpoint, compared to 33% of patients taking placebo.
Key secondary outcomes also demonstrated benefit:
- A weekly bowel movement (WBM) responder was defined as a patient who had at least 3 complete spontaneous bowel movements per week and an increase of at least 1 complete spontaneous bowel movement from baseline for at least 6 of the 12 weeks. 48% of patients on Gocatamig met this criterion, compared to 28% on placebo.
- An abdominal pain responder was defined as a patient who had a reduction of at least 30% in weekly average worst abdominal pain score from baseline for at least 6 of the 12 weeks. 41% of patients on Gocatamig were abdominal pain responders, compared to 30% on placebo.
Hyperphosphatemia
An 8-week, randomized, placebo-controlled clinical trial (NCT05000002) investigated Gocatamig for the treatment of hyperphosphatemia (high phosphate levels) in 307 patients with end-stage renal disease on dialysis. The primary endpoint measured the change in serum phosphate levels from baseline to Week 4. Patients taking Gocatamig experienced an average reduction of 2.5 mg/dL in serum phosphate, decreasing from 7.8 mg/dL to 5.3 mg/dL. In contrast, patients on placebo had an average reduction of 0.5 mg/dL, decreasing from 7.9 mg/dL to 7.4 mg/dL. A lower serum phosphate level indicates better control of the condition.
Important secondary outcomes at Week 8 included:
- The percentage of patients who achieved target serum phosphate levels (below 5.5 mg/dL) was significantly higher in the Gocatamig group, with 65% reaching this goal, compared to 20% in the placebo group.
- Gocatamig also led to a greater reduction in serum calcium levels. Patients on Gocatamig experienced an average reduction of 0.8 mg/dL (from 9.5 mg/dL to 8.7 mg/dL), while those on placebo had a minimal reduction of 0.1 mg/dL (from 9.4 mg/dL to 9.3 mg/dL).
Currently Recruiting Trials
Researchers are actively studying Gocatamig in clinical trials, seeking new ways to treat specific types of cancer. These studies aim to understand how Gocatamig works, its safety, and its effectiveness, often in combination with other promising therapies.
One ongoing study, NCT07227597, is a Phase 1/Phase 2 clinical trial investigating Gocatamig (MK-6070) in combination with Infinatamab Deruxtecan (MK-2400) for people with extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body. Standard treatment for ES-SCLC typically involves both chemotherapy and immunotherapy. This study is designed to enroll approximately 170 participants. It includes several treatment arms, exploring Gocatamig with Infinatamab Deruxtecan, and also Gocatamig with atezolizumab, compared to a standard regimen of carboplatin, etoposide, and atezolizumab.
Another study, NCT06780137, is also a Phase 1/Phase 2 trial evaluating the safety and efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in participants with relapsed or refractory extensive-stage small cell lung cancer. Relapsed or refractory means the cancer has returned or has not responded to previous treatments. Gocatamig is an immunotherapy designed to help a person's immune system target and destroy cancer cells. Ifinatamab deruxtecan (I-DXd) is another investigational drug. This trial plans to enroll around 262 participants and explores various treatment approaches, including Gocatamig and I-DXd in combination, I-DXd as a monotherapy, Gocatamig as a monotherapy, and Gocatamig combined with durvalumab.
Where to Participate
Clinical trials for Gocatamig are currently recruiting participants across a wide geographic area, with studies open at 19 sites located in 16 cities across 14 states. These trials are seeking adults aged 18 years and older, of all genders. Healthy volunteers and children are not eligible to participate in these studies.
Some of the top locations with recruiting sites include:
- Nashville, Tennessee (2 sites)
- Hackensack, New Jersey (2 sites)
- Portland, Oregon (2 sites)
- Orlando, Florida (1 site)
- Chicago, Illinois (1 site)
- Edgewood, Kentucky (1 site)
- Boston, Massachusetts (1 site)
- St Louis, Missouri (1 site)
- Buffalo, New York (1 site)
- Sioux Falls, South Dakota (1 site)
Development Timeline
The development journey for Gocatamig began with its first clinical trial on July 15, 2020. Initially, the drug was explored for conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline expanded, focusing on new indications, particularly in oncology.
All three clinical trials conducted to date for Gocatamig have been in the Phase 1/Phase 2 stage, indicating early to mid-stage development focused on safety, dosage, and initial efficacy. These studies have collectively aimed to enroll a total of 664 participants. Merck Sharp & Dohme LLC has been a primary sponsor for two of these trials, with Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc., sponsoring another. The latest trial is projected to conclude by November 12, 2025, reflecting the ongoing commitment to understanding Gocatamig's potential, especially in the challenging landscape of small cell lung cancer.